SMART CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S001 · decided 2006-05-12
Approval details
- PMA number
- P020036
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SMART CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2003-10-29
- Decision date
- 2006-05-12
- Days to decision
- 926 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CORDIS DE MEXICO, CHIHUAHUA, MEXICO.
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