PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
FDA premarket approval P110004 · decided 2012-04-12
Approval details
- PMA number
- P110004
- Trade name
- PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medinol, Ltd.
- Date received
- 2011-02-09
- Decision date
- 2012-04-12
- Days to decision
- 428 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tel-Aviv
- Statement
- APPROVAL FOR THE PRESILLION PLUS COCR CORONARY STENT ON RX SYSTEM. THIS DEVICE 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 <= 30 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM TO 4.00MM.
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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 |