Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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Published

June 8, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from January 1, 2021, through February 14, 2022. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff. This is the last notice of this kind considering FDA's rule discontinuing the practice of publishing such summaries in the Federal Register. As indicated in that rule, FDA will continue to publish to make available on the internet and place on public display summaries of safety and effectiveness for approved PMAs.

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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34884-34887]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-
2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-
2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-
2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-
2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-
2021-M-0766, FDA-2021-M-0676, FDA-2021-M-0690, FDA-2021-M-0656, FDA-
2021-M-0494, FDA-2021-M-0915, FDA-2021-M-0911, FDA-2021-M-0853, FDA-
2021-M-0805, FDA-2021-M-1046, FDA-2021-M-1010, FDA-2021-M-0991, FDA-
2021-M-0989, FDA-2021-M-0975, FDA-2021-M-0962, FDA-2021-M-1176, FDA-
2021-M-1119, FDA-2021-M-1116, FDA-2021-M-0532, FDA-2021-M-1058, FDA-
2021-M-1182, FDA-2021-M-1023, FDA-2021-M-1207, FDA-2021-M-1284, FDA-
2021-M-1271, FDA-2021-M-1317, FDA-2021-M-1321, FDA-2021-M-1316, FDA-
2021-M-1325, FDA-2021-M-1352, FDA-2022-M-0029, FDA-2022-M-0071, FDA-
2022-M-0087, FDA-2022-M-0089, FDA-2022-M-0090, and FDA-2022-M-0171].

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of premarket approval applications (PMAs) that have been
approved from January 1, 2021, through February 14, 2022. This list is
intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the internet and the
Agency's Dockets Management Staff. This is the last notice of this kind
considering FDA's rule discontinuing the practice of publishing such
summaries in the Federal Register. As indicated in that rule, FDA will
continue to publish to make available on the internet and place on
public display summaries of safety and effectiveness for approved PMAs.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178,
FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303,
FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355,
FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531,
FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766,
FDA-2021-M-0676, FDA-

[[Page 34885]]

2021-M-0690, FDA-2021-M-0656, FDA-2021-M-0494, FDA-2021-M-0915, FDA-
2021-M-0911, FDA-2021-M-0853, FDA-2021-M-0805, FDA-2021-M-1046, FDA-
2021-M-1010, FDA-2021-M-0991, FDA-2021-M-0989, FDA-2021-M-0975, FDA-
2021-M-0962, FDA-2021-M-1176, FDA-2021-M-1119, FDA-2021-M-1116, FDA-
2021-M-0532, FDA-2021-M-1058, FDA-2021-M-1182, and FDA-2021-M-1023,
FDA-2021-M-1207, FDA-2021-M-1284, FDA-2021-M-1271, FDA-2021-M-1317,
FDA-2021-M-1321, FDA-2021-M-1316, FDA-2021-M-1325, FDA-2021-M-1352,
FDA-2022-M-0029, FDA-2022-M-0071, FDA-2022-M-0087, FDA-2022-M-0089,
FDA-2022-M-0090, and FDA-2022-M-0171 for ``Medical Devices;
Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Dharmesh Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289,
<a href="/cdn-cgi/l/email-protection#eda9858c9f80889e85c3bd8c998881ad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="682c00091a050d1b004638091c0d04280e0c094600001b460f071e">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is published in the Federal Register.
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a
PMA may be sought only by the applicant; in these cases, the 30-day
period will begin when the applicant is notified by FDA in writing of
its decision.
Prior to February 14, 2022, the regulations provided that FDA
publish a list of available safety and effectiveness summaries of PMA
approvals and denials that were announced in the Federal Register. FDA
issued a rule discontinuing this practice on January 13, 2022 (87 FR
2042). At that time, FDA committed to continue to publish lists of
safety and effectiveness summaries of PMA approvals and denials on its
website. The following list of approved PMAs for which summaries of
safety and effectiveness that were placed on the internet from January
1, 2021, through February 14, 2022, will, therefore, be our last such
list to be published in this manner. There were no denial actions
during this period. The list in table 1 provides the manufacturer's
name, the product's generic name or trade name, and the approval date.

Table 1--List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries
for Approved HDEs Made Available From January 1, 2021, Through February 14, 2022
----------------------------------------------------------------------------------------------------------------
Approval
PMA No., docket No. Applicant Trade name date
----------------------------------------------------------------------------------------------------------------
P200003, FDA-2021-M-0070................ Seno Medical Instruments, Imagio[supreg] Breast Imaging 1/11/21
Inc. System.
P200028, FDA-2021-M-0135................ Medtronic, Inc............ DiamondTempTM Ablation System 1/28/2021
consisting of DiamondTempTM
AblaDiamondTemp Ablation
Catheter (Models CEDT100S,
CEDT200L, CEDTB300S,
CEDTB400L); DiamondTempTM RF
Generator (Model CEDTG200);
DiamondTempTM Irrigation
Pump (Model CEDTP100);
DiamondTempTM Irrigation
Tubing Set (Model
CEDTTS100); DiamondTempTM
Catheter-to-RF Generator
Cable (Model CEDTC100);
DiamondTempTM GenConnect
Cable (Model CEDTGC100);
DiamondTempTM EGM Cable
(Model CEDTEGM100).
P140029/S027, FDA-2021-M-0153........... Q-Med AB.................. Restylane[supreg] Defyne..... 1/29/2021
P190005, FDA-2021-M-0178................ Roche Diagnostics......... Elecsys Anti-HBe, 2/3/2021
PreciControl Anti-HBe.
P200039, FDA-2021-M-0202................ Shockwave Medical, Inc.... Shockwave Intravascular 2/12/2021
Lithotripsy (IVL) System
with the Shockwave C\2\
Coronary Intravascular
Lithotripsy (IVL) Catheter.
P190013, FDA-2021-M-0288................ AED Battery Exchange, LLC. AED Battery Exchange (Models 2/13/2021
9146-ABE, G5-ABE, 5070-ABE,
FR3-ABE).

[[Page 34886]]

H200001, FDA-2021-M-0203................ Additive Orthopaedics, LLC Patient Specific Talus Spacer 2/17/2021
P190034, FDA-2021-M-0228................ Roche Diagnostics......... Elecsys Anti-HBs II, 2/23/2021
PreciControl Anti-HBs, Anti-
HBs CalCheck.
P200029, FDA-2021-M-0303................ Boston Scientific TheraSphereTM................ 3/17/2021
Corporation.
P200025, FDA-2021-M-0325................ Bausch Health............. ClearVisc Ophthalmic 3/23/2021
Viscosurgical Device (OVD).
P200046, FDA-2021-M-0354................ Medtronic, Inc............ Medtronic Harmony 3/26/2021
Transcatheter Pulmonary
Valve (TPV) System.
P200022/S003, FDA-2021-M-0355........... Simplify Medical, Inc..... Simplify[supreg] Cervical 4/1/2021
Artificial Disc.
P200019, FDA-2021-M-0416................ Ventana Medical Systems, VENTANA MMR RxDx Panel....... 4/22/2021
Inc.
P980040/S124, FDA-2021-M-0421........... Johnson & Johnson Surgical TECNIS SynergyTM IOL, Model 4/28/2021
Vision, Inc. ZFR00V, TECNIS SynergyTM
Toric II IOL, Models ZFW150,
ZFW225, ZFW300, ZFW375,
TECNIS SynergyTM IOL with
TECNIS SimplicityTM Delivery
System, Model DFR00V, TECNIS
SynergyTM Toric II IOL with
TECNIS SimplicityTM Delivery
System, Model DFW150,
DFW225, DFW300, DFW375.
P200002, FDA-2021-M-0418................ AtriCure, Inc............. EPi-Sense[supreg] Guided 4/28/21
Coagulation System.
P140031/S125, FDA-2021-M-0473........... Edwards Lifesciences, LLC. Edwards SAPIEN 3 and SAPIEN 3 5/13/21
Ultra Transcatheter Heart
Valve System.
P200010/S001, FDA-2021-M-0520........... Guardant Health, Inc...... Guardant360 CDx.............. 5/21/2021
P110027/S012, FDA-2021-M-0531........... QIAGEN GmbH............... therascreen[supreg] KRAS RGQ 5/28/2021
PCR Kit.
P110033/S053, FDA-2021-M-0527........... Allergan.................. JUV[Eacute]DERM[supreg] 5/28/2021
VOLBELLA[supreg] XC.
P200010/S002, FDA-2021-M-0494........... Guardant Health, Inc...... Guardant360 CDx.............. 5/28/2021
P100010/S110, FDA-2021-M-0690........... Medtronic, Inc............ Arctic Front AdvanceTM 6/18/2021
Cardiac Cryoablation
Catheters, Arctic Front
Advance ProTM Cardiac
Cryoablation Catheters,
FreezorTM MAX Cardiac
Cryoablation Catheter,
CryoConsole Manual
Retraction Kit.
P200021, FDA-2021-M-0615................ Oticon Medical............ Neuro Cochlear Implant System 6/23/2021
P110019/S115, FDA-2021-M-0656........... Abbott Vascular........... XIENCE Alpine Everolimus 6/25/2021
Eluting Coronary Stent
Systems (XIENCE Alpine
EECSS), XIENCE Sierra
Everolimus Eluting Coronary
Stent Systems (XIENCE Sierra
EECSS), and the XIENCE
Skypoint Everolimus Eluting
Coronary Stent Systems
(XIENCE Skypoint EECSS).
P140029/S032, FDA-2021-M-0676........... Q-Med AB, a Galderma Restylane[supreg] Contour.... 6/28/2021
affiliate.
P200017, FDA-2021-M-0766................ Siemens Healthcare ADVIA Centaur[supreg] Anti- 7/14/2021
Diagnostics Inc. HBe2 (aHBe2) assay.
P190032/S001, FDA-2021-M-0707........... Foundation Medical, Inc... FoundationOne[supreg] Liquid 7/15/21
CDx (F1 Liquid).
P130022/S039, FDA-2021-M-0769........... Nervo Corporation......... Senza[supreg] Spinal Cord 7/16/2021
Stimulation (SCS) System.
P200037, FDA-2021-M-0820................ Kestra Medical ASSURE[supreg] Wearable 7/27/2021
Technologies, Inc. Cardioverter Defibrillator
(WCD) System (ASSURE System).
P200011, FDA-2021-M-0853................ Pillar Biosciences, Inc... ONCO/RevealTM Dx Lung & Colon 7/30/2021
Cancer Assay.
P200045, FDA-2021-M-0805................ Bolton Medical, Inc....... RelayPro Thoracic Stent-Graft 8/5/2021
System.
P200049, FDA-2021-M-0911................ Abbott Medical............ AmplatzerTM AmuletTM Left 8/14/2021
Atrial Appendage Occluder.
P210001, FDA-2021-M-0915................ Ventana Medical Systems, VENTANA MMR RxDx Panel....... 8/17/2021
Inc.
P160045/S028, FDA-2021-M-0962........... Life Technologies Oncomine[supreg] Dx Target 8/25/2021
Corporation. Test.
P210007, FDA-2021-M-0991................ MicroTransponder Inc...... MicroTransponder[supreg] 8/27/2021
Vivistim[supreg] Paired
VNSTM System
(Vivistim[supreg] System).
P050052/S129, FDA-2021-M-0975........... Merz North America, Inc... RADIESSE[supreg] (+) 9/1/2021
Lidocaine injectable implant.
P180051, FDA-2021-M-0989................ TransMedics, Inc.......... Organ Care System (OCSTM) 9/3/2021
Heart System.
P160045/S029, FDA-2021-M-1023........... Life Technologies OncomineTM Dx Target Test.... 9/15/2021
Corporation.
P190023, FDA-2021-M-1010................ Abbott Medical............ PorticoTM Transcatheter 9/17/2021
Aortic Valve Implantation
System: PorticoTM
Transcatheter Aortic Heart
Valve, FlexNavTM Delivery
System, FlexNavTM Loading
System.
P200004, FDA-2021-M-1046................ ConMed Corporation........ ConMed PadPro Multifunction 9/26/2021
Electrodes, ConMed PadPro
Multifunction Electrode
Adapters.
P200031, FDA-2021-M-1058................ TransMedics, Inc.......... Organ Care System (OCSTM) 9/28/2021
Liver.
P210026, FDA-2021-M-1116................ Agilent Technologies, Inc. Ki-67 IHC MIB-1 pharmDx (Dako 10/12/2021
Omnis).

[[Page 34887]]

P190012, FDA-2021-M-1119................ Spatz FGIA Inc............ Spatz3 Adjustable Balloon 10/15/2021
System.
P160046/S010, FDA-2021-M-0532........... Ventana Medical Systems, VENTANA PD-L1 (SP263) Assay.. 10/15/2021
Inc.
P150031/S040, FDA-2021-M-1176........... Boston Scientific Vercise PC, Vercise Gevia and 10/20/2021
Corporation. Vercise Genus DBS Systems.
P150038/S014, FDA-2021-M-1182........... INSIGHTEC, Inc............ Exablate Model 4000 Type 1.0 10/29/21
and 1.1 System (``Exablate
Neuro'').
P130026/S070, FDA-2021-M-1207........... Abbott Medical............ TactiCath Contact Force 11/4/21
Ablation Catheter, Sensor
Enabled (Uni-Directional);
TactiCath Contact Force
Ablation Catheter, Sensor
Enabled (Bi-Directional);
TactiSys Quartz Equipment;
Ampere RF Generator and Cool
Point Irrigation Pump.
P210020, FDA-2021-M-1284................ Urotronic, Inc............ Optilume[supreg] Urethral 12/3/21
Drug Coated Balloon.
P190022, FDA-2021-M-1271................ OPKO Health, Inc.......... 4Kscore[supreg] Test......... 12/7/21
P200035, FDA-2021-M-1317................ OrganOx Limited........... OrganOx metra[supreg] System. 12/9/21
P210014, FDA-2021-M-1321................ Svelte Medical Systems, SLENDER Sirolimus-Eluting 12/13/21
Inc. Coronary Stent Integrated
Delivery System and DIRECT
Sirolimus-Eluting Coronary
Stent Rapid Exchange
Delivery System.
P200041, FDA-2021-M-1316................ OrbusNeich Medical Scoreflex NC Scoring PTCA 12/21/21
(Shenzhen) Co., Ltd. Catheter.
P200015/S011, FDA-2021-M-1325........... Edwards Lifesciences LLC.. Edwards SAPIEN 3 12/16/21
Transcatheter Pulmonary
Valve System with Alterra
Adaptive Prestent.
P200040, FDA-2021-M-1352................ Delphinus Medical SoftVue Automated Whole 10/6/21
Technologies, Inc. Breast Ultrasound System
with Sequr Breast Interface
Assembly.
P170002/S012, FDA-2022-M-0029........... TEOXANE S.A............... RHA[supreg] RedensityTM...... 12/22/21
P970051/S205, FDA-2022-M-0071........... Cochlear Americas......... Nucleus 24 Cochlear Implant 1/10/22
System.
P130022/S042, FDA-2022-M-0087........... Nevro Corporation......... Senza[supreg] Spinal Cord 1/18/22
Stimulation (SCS) System.
P840001/S469, FDA-2022-M-089............ Medtronic Neuromodulation. Restore, Itrel, Synergy, 1/21/22
Intellis, and Vanta Spinal
Cord Stimulation Systems,
Pisces, Specify and Vectris
Spinal Cord Stimulation
Leads.
P080012/S068, FDA-2022-M-0090........... Flowonix Medical, Inc..... Prometra[supreg] Programmable 1/12/22
Infusion Pump System.
P160048/S016, FDA-2022-M-0171........... Senseonics, Incorporated.. Eversense[supreg] E3 2/10/22
Continuous Glucose
Monitoring System.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

Persons with access to the internet may obtain the documents at
<a href="https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm">https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm</a>.

Dated: June 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12371 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P

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