Covera™ Vascular Covered Stent

FDA Premarket Approval P170042 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: Covera™ Vascular Covered Stent
• Generic Name: System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
• Applicant: C.R. Bard, Inc1625 W. 3rd Streettempe, AZ 85528 PMA NumberP170042 Supplement NumberS011 Date Received08/20/2021 Decision Date03/24/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• Date Received: 2021-08-20
• Decision Date: 2022-03-24
• PMA: P170042
• Supplement: S011
• Product Code: PFV
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Pas
• Expedited Review: No
• Combination Product: No
• Applicant Address: C.R. Bard, Inc; 1625 W. 3rd Street; tempe, AZ 85528 PMA NumberP170042 Supplement NumberS011 Date Received08/20/2021 Decision Date03/24/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement ; approval For An Update To The Labeling To Include The 36-month Data On Patients Enrolled In The AVeNEW IDE Extended Follow-up Study (PAS001)

Supplemental Filings

Supplement Number	Date	Supplement Type
P170042		Original Filing
S012	2023-01-06	30-day Notice
S011	2021-08-20	Normal 180 Day Track No User Fee
S010	2021-07-09	30-day Notice
S009	2021-05-04	30-day Notice
S008	2020-09-01	30-day Notice
S007	2020-08-31	30-day Notice
S006	2020-08-03	30-day Notice
S005
S004
S003	2019-04-01	Normal 180 Day Track No User Fee
S002	2018-09-04	Panel Track
S001	2018-08-20	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
00801741106613	P170042	000
00801741106491	P170042	000
00801741106484	P170042	000
00801741106477	P170042	000
00801741106460	P170042	000
00801741106453	P170042	000
00801741106446	P170042	000
00801741106439	P170042	000
00801741106422	P170042	000
00801741106415	P170042	000
00801741106507	P170042	000
00801741106514	P170042	000
00801741106606	P170042	000
00801741106590	P170042	000
00801741106583	P170042	000
00801741106576	P170042	000
00801741106569	P170042	000
00801741106552	P170042	000
00801741106545	P170042	000
00801741106538	P170042	000
00801741106521	P170042	000
00801741106408	P170042	000
00801741106392	P170042	000
00801741106385	P170042	000
00801741106262	P170042	000
00801741106255	P170042	000
00801741106248	P170042	000
00801741106231	P170042	000
00801741106224	P170042	000
00801741106217	P170042	000
00801741106200	P170042	000
00801741106194	P170042	000
00801741106187	P170042	000
00801741106279	P170042	000
00801741106286	P170042	000
00801741106378	P170042	000
00801741106361	P170042	000
00801741106354	P170042	000
00801741106347	P170042	000
00801741106330	P170042	000
00801741106323	P170042	000
00801741106316	P170042	000
00801741106309	P170042	000
00801741106293	P170042	000
00801741106170	P170042	000
00801741107078	P170042	000
00801741106958	P170042	000
00801741106941	P170042	000
00801741106934	P170042	000
00801741106927	P170042	000
00801741106910	P170042	000
00801741106903	P170042	000
00801741106897	P170042	000
00801741106873	P170042	000
00801741106866	P170042	000
00801741106965	P170042	000
00801741106972	P170042	000
00801741107061	P170042	000
00801741107054	P170042	000
00801741107047	P170042	000
00801741107030	P170042	000
00801741107023	P170042	000
00801741107016	P170042	000
00801741107009	P170042	000
00801741106996	P170042	000
00801741106989	P170042	000
00801741106859	P170042	000
00801741106842	P170042	000
00801741106835	P170042	000
00801741106712	P170042	000
00801741106705	P170042	000
00801741106699	P170042	000
00801741106682	P170042	000
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00801741106668	P170042	000
00801741106651	P170042	000
00801741106644	P170042	000
00801741106637	P170042	000
00801741106729	P170042	000
00801741106736	P170042	000
00801741106828	P170042	000
00801741106811	P170042	000
00801741106804	P170042	000
00801741106798	P170042	000
00801741106781	P170042	000
00801741106774	P170042	000
00801741106767	P170042	000
00801741106750	P170042	000
00801741106743	P170042	000
00801741106620	P170042	000