Astron Pulsar Stent System and Pulsar-18 Stent System
FDA PMAClass III (US FDA PMA)
by Biotronik AG
Identity
- Trade Name
- ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM FDA PMA
- Generic Name
- STENT, SUPERFICIAL FEMORAL ARTERY FDA PMA
Identifiers
- PMA Number
- P160025 FDA PMA
- FDA Product Code
- NIP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Astron Pulsar Stent System and Pulsar-18 Stent System are superficial femoral artery stents designed to improve luminal diameter in patients. These devices are indicated for use in symptomatic de novo, restenotic, or occlusive lesions located in the superficial femoral or proximal popliteal arteries.
These systems are intended for vessels with reference diameters ranging from 3.0 to 6.0mm and total lesion lengths up to 190mm. The devices have received FDA PMA authorization for clinical use. Please consult the product labeling for specific information regarding storage, sterility, and procedural application.
Frequently asked questions
What is the primary indication for the Astron Pulsar Stent System?
The system is indicated to improve luminal diameter in patients suffering from symptomatic de novo, restenotic, or occlusive lesions within the superficial femoral or proximal popliteal arteries.
What vessel sizes are compatible with these stent systems?
These stent systems are designed for use in vessels with reference diameters between 3.0mm and 6.0mm and are suitable for treating total lesion lengths up to 190mm.
Has this device received regulatory authorization?
Yes, the Astron Pulsar Stent System and Pulsar-18 Stent System have received FDA PMA (Premarket Approval) authorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Astron (Unternehmen) – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160025 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik AG
Sources (1)
- FDA PMA P160025 24 fields · synced Sep 18, 2026