34884 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

MD 20993–0002, 301–796–7699, email: 

PCNS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Peripheral and Central 

Nervous System Drugs Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of neurologic 

diseases. 

The Committee shall consist of a core 

of nine voting members, including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

neurology, neuropharmacology, 

neuropathology, otolaryngology, 

epidemiology or statistics, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Non-Federal members of this 

committee will serve as Special 

Government Employees, representatives 

or ex-officio members. Federal members 

will serve as Regular Government 

Employees or ex-officio members. The 

core of voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting representative member 

who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

peripheral-and-central-nervous-systemdrugs-advisory-committee/peripheraland-central-nervous-system-drugsadvisory-committee-charter or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12368 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov 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 https://www.regulations.gov. 

• 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: 

• 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. 

• 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– 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 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 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 

https://www.regulations.gov. 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: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov 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, 

Dharmesh.Patel@fda.hhs.gov. 

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 

§ 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 

PMA No., docket No. Applicant Trade name Approval 

date 

P200003, FDA–2021–M–0070 .... Seno Medical Instruments, Inc ... Imagio® Breast Imaging System .......................................... 1/11/21 

P200028, FDA–2021–M–0135 .... Medtronic, Inc ............................. DiamondTempTM Ablation System 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).

1/28/2021 

P140029/S027, FDA–2021–M– 

0153.

Q-Med AB ................................... Restylane® Defyne ............................................................... 1/29/2021 

P190005, FDA–2021–M–0178 .... Roche Diagnostics ..................... Elecsys Anti-HBe, PreciControl Anti-HBe ............................ 2/3/2021 

P200039, FDA–2021–M–0202 .... Shockwave Medical, Inc ............. Shockwave Intravascular Lithotripsy (IVL) System with the 

Shockwave C2 Coronary Intravascular Lithotripsy (IVL) 

Catheter.

2/12/2021 

P190013, FDA–2021–M–0288 .... AED Battery Exchange, LLC ...... AED Battery Exchange (Models 9146–ABE, G5–ABE, 

5070–ABE, FR3–ABE).

2/13/2021 


khammond on DSKJM1Z7X2PROD with NOTICES
34886 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

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— 

Continued 

PMA No., docket No. Applicant Trade name Approval 

date 

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, PreciControl Anti-HBs, Anti-HBs 

CalCheck.

2/23/2021 

P200029, FDA–2021–M–0303 .... Boston Scientific Corporation ..... TheraSphereTM ..................................................................... 3/17/2021 

P200025, FDA–2021–M–0325 .... Bausch Health ............................ ClearVisc Ophthalmic Viscosurgical Device (OVD) ............. 3/23/2021 

P200046, FDA–2021–M–0354 .... Medtronic, Inc ............................. Medtronic Harmony Transcatheter Pulmonary Valve (TPV) 

System.

3/26/2021 

P200022/S003, FDA–2021–M– 

0355.

Simplify Medical, Inc .................. Simplify® Cervical Artificial Disc ........................................... 4/1/2021 

P200019, FDA–2021–M–0416 .... Ventana Medical Systems, Inc ... VENTANA MMR RxDx Panel ............................................... 4/22/2021 

P980040/S124, FDA–2021–M– 

0421.

Johnson & Johnson Surgical Vision, Inc.TECNIS SynergyTM IOL, Model 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.

4/28/2021 

P200002, FDA–2021–M–0418 .... AtriCure, Inc ............................... EPi-Sense® Guided Coagulation System ............................ 4/28/21 

P140031/S125, FDA–2021–M– 

0473.

Edwards Lifesciences, LLC ........ Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter 

Heart Valve System.

5/13/21 

P200010/S001, FDA–2021–M– 

0520.

Guardant Health, Inc .................. Guardant360 CDx ................................................................. 5/21/2021

P110027/S012, FDA–2021–M– 

0531.

QIAGEN GmbH .......................... therascreen® KRAS RGQ PCR Kit ...................................... 5/28/2021 

P110033/S053, FDA–2021–M– 

0527.

Allergan ...................................... JUVE ́ DERM® VOLBELLA® XC ............................................ 5/28/2021 

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 Cardiac Cryoablation Catheters, 

Arctic Front Advance ProTM Cardiac Cryoablation Catheters, FreezorTM MAX Cardiac Cryoablation Catheter, 

CryoConsole Manual Retraction Kit.

6/18/2021 

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 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).

6/25/2021 

P140029/S032, FDA–2021–M– 

0676.

Q-Med AB, a Galderma affiliate Restylane® Contour .............................................................. 6/28/2021 

P200017, FDA–2021–M–0766 .... Siemens Healthcare Diagnostics 

Inc.

ADVIA Centaur® Anti-HBe2 (aHBe2) assay ........................ 7/14/2021 

P190032/S001, FDA–2021–M– 

0707.

Foundation Medical, Inc ............. FoundationOne® Liquid CDx (F1 Liquid) ............................. 7/15/21 

P130022/S039, FDA–2021–M– 

0769.

Nervo Corporation ...................... Senza® Spinal Cord Stimulation (SCS) System .................. 7/16/2021 

P200037, FDA–2021–M–0820 .... Kestra Medical Technologies, 

Inc.

ASSURE® Wearable Cardioverter Defibrillator (WCD) System (ASSURE System).7/27/2021 

P200011, FDA–2021–M–0853 .... Pillar Biosciences, Inc ................ ONCO/RevealTM Dx Lung & Colon Cancer Assay .............. 7/30/2021 

P200045, FDA–2021–M–0805 .... Bolton Medical, Inc ..................... RelayPro Thoracic Stent-Graft System ................................ 8/5/2021 

P200049, FDA–2021–M–0911 .... Abbott Medical ............................ AmplatzerTM AmuletTM Left Atrial Appendage Occluder ...... 8/14/2021 

P210001, FDA–2021–M–0915 .... Ventana Medical Systems, Inc ... VENTANA MMR RxDx Panel ............................................... 8/17/2021 

P160045/S028, FDA–2021–M– 

0962.

Life Technologies Corporation ... Oncomine® Dx Target Test .................................................. 8/25/2021 

P210007, FDA–2021–M–0991 .... MicroTransponder Inc ................ MicroTransponder® Vivistim® Paired VNSTM System 

(Vivistim® System).

8/27/2021 

P050052/S129, FDA–2021–M– 

0975.

Merz North America, Inc ............ RADIESSE® (+) Lidocaine injectable implant ...................... 9/1/2021 

P180051, FDA–2021–M–0989 .... TransMedics, Inc ........................ Organ Care System (OCSTM) Heart System ....................... 9/3/2021 

P160045/S029, FDA–2021–M– 

1023.

Life Technologies Corporation ... OncomineTM Dx Target Test ................................................ 9/15/2021 

P190023, FDA–2021–M–1010 .... Abbott Medical ............................ PorticoTM Transcatheter Aortic Valve Implantation System: 

PorticoTM Transcatheter Aortic Heart Valve, FlexNavTM

Delivery System, FlexNavTM Loading System.

9/17/2021 

P200004, FDA–2021–M–1046 .... ConMed Corporation .................. ConMed PadPro Multifunction Electrodes, ConMed PadPro 

Multifunction Electrode Adapters.

9/26/2021 

P200031, FDA–2021–M–1058 .... TransMedics, Inc ........................ Organ Care System (OCSTM) Liver ..................................... 9/28/2021 

P210026, FDA–2021–M–1116 .... Agilent Technologies, Inc ........... Ki-67 IHC MIB–1 pharmDx (Dako Omnis) ........................... 10/12/2021 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34887 

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— 

Continued 

PMA No., docket No. Applicant Trade name Approval 

date 

P190012, FDA–2021–M–1119 .... Spatz FGIA Inc ........................... Spatz3 Adjustable Balloon System ...................................... 10/15/2021 

P160046/S010, FDA–2021–M– 

0532.

Ventana Medical Systems, Inc ... VENTANA PD–L1 (SP263) Assay ....................................... 10/15/2021 

P150031/S040, FDA–2021–M– 

1176.

Boston Scientific Corporation ..... Vercise PC, Vercise Gevia and Vercise Genus DBS Systems.10/20/2021 

P150038/S014, FDA–2021–M– 

1182.

INSIGHTEC, Inc ......................... Exablate Model 4000 Type 1.0 and 1.1 System (‘‘Exablate 

Neuro’’).

10/29/21 

P130026/S070, FDA–2021–M– 

1207.

Abbott Medical ............................ TactiCath Contact Force 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.

11/4/21 

P210020, FDA–2021–M–1284 .... Urotronic, Inc .............................. Optilume® Urethral Drug Coated Balloon ............................ 12/3/21 

P190022, FDA–2021–M–1271 .... OPKO Health, Inc ....................... 4Kscore® Test ...................................................................... 12/7/21 

P200035, FDA–2021–M–1317 .... OrganOx Limited ........................ OrganOx metra® System ...................................................... 12/9/21 

P210014, FDA–2021–M–1321 .... Svelte Medical Systems, Inc ...... SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary 

Stent Rapid Exchange Delivery System.

12/13/21 

P200041, FDA–2021–M–1316 .... OrbusNeich Medical (Shenzhen) 

Co., Ltd.

Scoreflex NC Scoring PTCA Catheter ................................. 12/21/21 

P200015/S011, FDA–2021–M– 

1325.

Edwards Lifesciences LLC ......... Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent.12/16/21 

P200040, FDA–2021–M–1352 .... Delphinus Medical Technologies, 

Inc.

SoftVue Automated Whole Breast Ultrasound System with 

Sequr Breast Interface Assembly.

10/6/21 

P170002/S012, FDA–2022–M– 

0029.

TEOXANE S.A ........................... RHA® RedensityTM ............................................................... 12/22/21 

P970051/S205, FDA–2022–M– 

0071.

Cochlear Americas ..................... Nucleus 24 Cochlear Implant System .................................. 1/10/22 

P130022/S042, FDA–2022–M– 

0087.

Nevro Corporation ...................... Senza® Spinal Cord Stimulation (SCS) System .................. 1/18/22 

P840001/S469, FDA–2022–M– 

089.

Medtronic Neuromodulation ....... Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord 

Stimulation Systems, Pisces, Specify and Vectris Spinal 

Cord Stimulation Leads.

1/21/22 

P080012/S068, FDA–2022–M– 

0090.

Flowonix Medical, Inc ................. Prometra® Programmable Infusion Pump System ............... 1/12/22 

P160048/S016, FDA–2022–M– 

0171.

Senseonics, Incorporated ........... Eversense® E3 Continuous Glucose Monitoring System .... 2/10/22 

II. Electronic Access 

Persons with access to the internet 

may obtain the documents at https://

www.fda.gov/MedicalDevices/ 

ProductsandMedicalProcedures/Device

ApprovalsandClearances/ 

PMAApprovals/default.htm. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: HRSA Ryan 

White HIV/AIDS Program HIV Quality 

Measures Module, OMB No. 0906– 

0022—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than August 8, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 


khammond on DSKJM1Z7X2PROD with NOTICES