S.M.A.R.T. RADIANZ Vascular Stent System
FDA premarket approval P020036/S045 · decided 2022-02-25
Approval details
- PMA number
- P020036
- Supplement
- S045
- 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, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2021-09-01
- Decision date
- 2022-02-25
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for a new delivery system to allow use with a transradial approach.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.