PRO-Kinetic Energy Coronary Stent System, Papyrus
FDA premarket approval P160003/S008 · decided 2019-06-05
Approval details
- PMA number
- P160003
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRO-Kinetic Energy Coronary Stent System, Papyrus
- Generic name
- STENT, CORONARY
- Applicant
- Biotronik AG
- Date received
- 2019-05-06
- Decision date
- 2019-06-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Replace the manual lot verification for PRO-Kinetic Energy Coronary Stent System with an automated lot verification station.
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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 |