Covera Vascular Covered Stent
FDA premarket approval P170042/S011 · decided 2022-03-24
Approval details
- PMA number
- P170042
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Covera Vascular Covered Stent
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- C.R. Bard, Inc.
- Date received
- 2021-08-20
- Decision date
- 2022-03-24
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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