Astron Pulsar; Pulsar-18; Pulsar-18 T3
FDA premarket approval P160025/S023 · decided 2025-12-17
Approval details
- PMA number
- P160025
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Astron Pulsar; Pulsar-18; Pulsar-18 T3
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Biotronik AG
- Date received
- 2025-11-26
- Decision date
- 2025-12-17
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- new hydrogen content testing equipment
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |