S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
FDA premarket approval P120002/S009 · decided 2015-11-25
Approval details
- PMA number
- P120002
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2015-03-19
- Decision date
- 2015-11-25
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
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