Cordis® PRECISE® Nitinol Stent System
FDA premarket approval P030047/S045 · decided 2022-12-07
Approval details
- PMA number
- P030047
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cordis® PRECISE® Nitinol Stent System
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2022-11-07
- Decision date
- 2022-12-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- New polyimide supplier.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.