S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S055 · decided 2025-05-28
Approval details
- PMA number
- P020036
- Supplement
- S055
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2025-04-28
- Decision date
- 2025-05-28
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- approval for updates to the labeling including instructions for use, implant card, and packaging labels.
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