Covera Vascular Covered Stents
FDA premarket approval P170042/S013 · decided 2025-06-26
Approval details
- PMA number
- P170042
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Covera Vascular Covered Stents
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- C.R. Bard, Inc.
- Date received
- 2025-05-30
- Decision date
- 2025-06-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- qualification of an additional manufacturing facility for the stent covering process for the Covera Vascular Covered Stent
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