S.M.A.R.T. RADIANZ Vascular Stent System
FDA premarket approval P120002/S020 · decided 2022-02-25
Approval details
- PMA number
- P120002
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- S.M.A.R.T. RADIANZ Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2021-09-01
- Decision date
- 2022-02-25
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for a new delivery system to allow use with a transradial approach.
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