SMART & SMART CONTROL NITINOL STENT SYSTEMS
FDA premarket approval P020036/S020 · decided 2011-01-31
Approval details
- PMA number
- P020036
- Supplement
- S020
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SMART & SMART CONTROL NITINOL STENT SYSTEMS
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2010-08-09
- Decision date
- 2011-01-31
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A CHANGE TO THE TEMPERATURE SET POINT IN YOUR SUB- ASSEMBLY PROCESS.
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