CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
FDA premarket approval P030047/S001 · decided 2006-11-16
Approval details
- PMA number
- P030047
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2006-09-27
- Decision date
- 2006-11-16
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE PRECISE? RX NITINOL STENT SYSTEM.
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