Astron Pulsar/Pulsar-18 Stent System
FDA premarket approval P160025/S002 · decided 2017-08-07
Approval details
- PMA number
- P160025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Astron Pulsar/Pulsar-18 Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Biotronik AG
- Date received
- 2017-06-14
- Decision date
- 2017-08-07
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for the final PMA PAS Protocol Administrative Addendum (dated June 6, 2017) containing the PAS long-term data analysis plan and for extending the Post-Approval Study (PAS) reporting frequency from 6 months to 12 months.
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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 |