CORDIS PRECISE NITINOL STENT SYSTEM
FDA premarket approval P030047/S012 · decided 2008-09-10
Approval details
- PMA number
- P030047
- Supplement
- S012
- Supplement type
- 135 Review Track For 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
- 2008-02-06
- Decision date
- 2008-09-10
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A CHANGE TO THE INCOMING INSPECTION SPECIFICATIONS FOR THE RAW MATERIAL USED FOR THE HYPOTUBE COMPONENT.
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