PRO-Kinetic Energy Stent System
FDA premarket approval P160003/S010 · decided 2020-08-06
Approval details
- PMA number
- P160003
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRO-Kinetic Energy Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Biotronik AG
- Date received
- 2020-07-09
- Decision date
- 2020-08-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- New equipment for balloon manufacturing and modifying the sampling plan for final release testing.
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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 |