SMART CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S002 · decided 2004-03-19
Approval details
- PMA number
- P020036
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SMART CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2003-11-24
- Decision date
- 2004-03-19
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE FOLLOWING CHANGE TO THE DELIVER SYSTEM OF THE S.M.A.R.T. CONTROL NITINOL STENT SYSTEM: 1) THE WIRE LUMEN OF THE DELIVERY SYSTEM WILL BE FABRICATED FROM DIFFERENT MATERIALS. 2) THE NEW WIRE LUMEN INNER DIAMETER SPECIFICATION HAS BEEN INCREASED. 3) THE PROXIMAL LAND SECTION OF THE DISTAL TIP HAS BEEN INCREASED. 4) THE INNER DIAMETER SPECIFICATION OF THE DISTAL TIP HAS BEEN INCREASE.
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