EluNIR Ridaforolimus Eluting Coronary Stent System
FDA premarket approval P170008/S032 · decided 2021-08-20
Approval details
- PMA number
- P170008
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medinol, Ltd.
- Date received
- 2021-02-22
- Decision date
- 2021-08-20
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel Aviv
- Statement
- Approval for updates to the device labeling reflecting the 5-year continued follow-up of the BIONICS Clinical Study.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Gallant PTCA Dilatation Catheter (K173581) | Medinol, Ltd. | 2018-01-25 |
| NC Gallant PTCA Catheter (K162434) | Medinol, Ltd. | 2017-01-19 |
| X-Suit NIR Biliary Metallic Stent (K150487) | Medinol, Ltd. | 2016-02-12 |
| MEDINOL X-SUIT NIR BILIARY METALLIC STENT (K081956) | Medinol, Ltd. | 2009-01-09 |
| NIR BILIARY STENT (K002130) | Medinol, Ltd. | 2000-10-30 |
| NIR BILIARY STENT (K973171) | Medinol, Ltd. | 1998-11-13 |