Covera Vascular Covered Stent
FDA premarket approval P170042/S005 · decided 2020-10-07
Approval details
- PMA number
- P170042
- Supplement
- S005
- 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
- 2020-04-13
- Decision date
- 2020-10-07
- Days to decision
- 177 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 24-month data on patients enrolled in the AVeVA clinical study.
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