EluNIR Ridaforolimus Eluting Coronary Stent System
FDA premarket approval P170008/S010 · decided 2018-11-16
Approval details
- PMA number
- P170008
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medinol, Ltd.
- Date received
- 2018-10-19
- Decision date
- 2018-11-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel Aviv
- Statement
- Addition of a semi-automatic flare machine for manufacturing the delivery system.
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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 |