PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
FDA premarket approval P030047/S017 · decided 2009-04-22
Approval details
- PMA number
- P030047
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2009-03-26
- Decision date
- 2009-04-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- MODIFICATIONS TO THE DELIVERY SYSTEM BONDING PROCESS.
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