ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
FDA premarket approval P140030 · decided 2015-12-17
Approval details
- PMA number
- P140030
- Trade name
- ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Biotronik AG
- Date received
- 2014-12-18
- Decision date
- 2015-12-17
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- APPROVAL FOR THE ASTRON PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETERIN PATIENTS WITH ILIAC ATHEROSCLEROTIC LESIONS IN VESSEL REFERENCE DIAMETERS BETWEEN 4.3MM AND9.5MM AND LESION LENGTHS UP TO 105MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |