Covera Vascular Covered Stent
FDA premarket approval P170042/S003 · decided 2019-10-31
Approval details
- PMA number
- P170042
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2019-04-01
- Decision date
- 2019-10-31
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of the protocols for the post-approval studies (PAS) protocol.
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