EluNIR Ridaforolimus Eluting Coronary Stent System
FDA premarket approval P170008/S019 · decided 2019-11-19
Approval details
- PMA number
- P170008
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medinol, Ltd.
- Date received
- 2019-07-10
- Decision date
- 2019-11-19
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel Aviv
- Statement
- Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=36mm in length in native coronary arteries with reference diameter of 2.50mm to 4.25mm.
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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 |