CORDIS PRECISE NITINOL STENT SYSTEMS
FDA premarket approval P030047/S030 · decided 2016-01-04
Approval details
- PMA number
- P030047
- Supplement
- S030
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS PRECISE NITINOL STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2015-04-27
- Decision date
- 2016-01-04
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR REPLACEMENT OF A RAW MATERIAL SUPPLIER.
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