PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
FDA premarket approval P160003 · decided 2017-02-14
Approval details
- PMA number
- P160003
- Trade name
- PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Biotronik AG
- Date received
- 2016-01-19
- Decision date
- 2017-02-14
- Days to decision
- 392 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Approval for the PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2.25 mm to 4.0 mm and lesion length <= 31 mm.
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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 |