ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
FDA premarket approval P160025 · decided 2017-03-23
Approval details
- PMA number
- P160025
- Trade name
- ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Biotronik AG
- Date received
- 2016-07-22
- Decision date
- 2017-03-23
- Days to decision
- 244 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for the Astron Pulsar Stent System and Pulsar-18 Stent System. These devices are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0mm and total lesion lengths up to 190mm.
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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 |