NIRXCELL COCR CORONARY STENT ON RX SYSTEM
FDA premarket approval P110004/S001 · decided 2013-12-19
Approval details
- PMA number
- P110004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIRXCELL COCR CORONARY STENT ON RX SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medinol, Ltd.
- Date received
- 2013-02-22
- Decision date
- 2013-12-19
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel-Aviv
- Statement
- APPROVAL FOR MODIFICATIONS TO THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NIRXCELL COCR CORONARY STENT ON RX SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH ¿30MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50MM TO 4.00MM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |