CORDIS PRECISE NITINOL STENT
FDA premarket approval P030047/S009 · decided 2008-04-14
Approval details
- PMA number
- P030047
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CORDIS PRECISE NITINOL STENT
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2007-11-21
- Decision date
- 2008-04-14
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING TO INCLUDE THE POST-APPROVAL STUDIES FINDINGS.
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