CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM
FDA premarket approval P030047/S011 · decided 2008-09-30
Approval details
- PMA number
- P030047
- Supplement
- S011
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2008-02-05
- Decision date
- 2008-09-30
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR REDUCING THE SAMPLE SIZE FOR THE FOLLOWING PROCESSES: 1) THE FUSING OPERATION FOR ALL PRECISE DEVICES AND THE SEALING OPERATION FOR PRECISE RX; AND 2) THE BONDING PROCESS OF THE PRECISE RX AND PRECISE PRO RX SUPPORT MEMBER/WIRE LUMEN SUBASSEMBLY.
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