PRO-Kinetic Energy Coronary Stent System
FDA premarket approval P160003/S006 · decided 2019-04-25
Approval details
- PMA number
- P160003
- Supplement
- S006
- Supplement type
- 135 Review Track For 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
- 2018-06-29
- Decision date
- 2019-04-25
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for automation of an existing inspection process.
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 |