NIRFLEX PREMOUNTED STENT
FDA premarket approval P020040 · decided 2003-10-24
Approval details
- PMA number
- P020040
- Trade name
- NIRFLEX PREMOUNTED STENT
- Generic name
- STENT, CORONARY
- Applicant
- Medinol, Ltd.
- Date received
- 2002-09-25
- Decision date
- 2003-10-24
- Days to decision
- 394 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel Aviv
- Statement
- APPROVAL FOR THE NIRFLEX PRE-MOUNTED CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO AND RESTENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER FROM 2.5 MM TO 4.0 MM.
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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 |