SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S012 · decided 2008-12-11
Approval details
- PMA number
- P020036
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2008-12-03
- Decision date
- 2008-12-11
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS SMART STENT SYSTEMS.
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