PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
FDA premarket approval P030047/S052 · decided 2025-10-21
Approval details
- PMA number
- P030047
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2025-09-26
- Decision date
- 2025-10-21
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica
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