PRO-Kinetic Energy Coronary Stent System
FDA premarket approval P160003/S002 · decided 2018-04-25
Approval details
- PMA number
- P160003
- Supplement
- S002
- 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
- 2017-04-19
- Decision date
- 2018-04-25
- Days to decision
- 371 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for modifications to the incubation conditions used during bioburden testing of the product and environment.
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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 |