PRECISE Pro Rx Nitinol Stent System
FDA premarket approval P030047/S041 · decided 2021-04-01
Approval details
- PMA number
- P030047
- Supplement
- S041
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISE Pro Rx Nitinol Stent System
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2021-03-03
- Decision date
- 2021-04-01
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for changes to the tip pull test.
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