Covera Vascular Covered Stent
FDA premarket approval P170042/S009 · decided 2021-06-03
Approval details
- PMA number
- P170042
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2021-05-04
- Decision date
- 2021-06-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- New supplier and manufacturing processes for delivery system handle components.
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