PRO-Kinetic Energy Coronary Stent System
FDA premarket approval P160003/S025 · decided 2025-07-10
Approval details
- PMA number
- P160003
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRO-Kinetic Energy Coronary Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Biotronik AG
- Date received
- 2025-06-13
- Decision date
- 2025-07-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- the introduction of a new hardware control logic unit for process ovens used in the manufacture of your coronary and peripheral stent systems
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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 |