S.M.A.R.T CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S010 · decided 2008-08-07
Approval details
- PMA number
- P020036
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S.M.A.R.T CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2008-07-18
- Decision date
- 2008-08-07
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL TO INCORPORATE A FUNCTIONAL TORQUE SPECIFICATION FOR THE SLIDER ASSEMBLY OF THE SMART CONTROL NITINOL STENT DELIVERY SYSTEM.
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