CORDIS SMART CONTROL VASCULAR STENT SYSTEMS
FDA premarket approval P120002/S003 · decided 2014-05-12
Approval details
- PMA number
- P120002
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS SMART CONTROL VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2014-04-16
- Decision date
- 2014-05-12
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- CHANGE IN MANUFACTURING FACILITY FOR THE SUPPLIER OF THE SLIDER ASSEMBLY AND HANDLE AND THE INTRODUCTION OF A NEW MOLDING MACHINE.
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