S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S037 · decided 2016-06-09
Approval details
- PMA number
- P020036
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2016-05-02
- Decision date
- 2016-06-09
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for changes to the MR labeling.
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