COBRA PzF NanoCoated Coronary Stent System
FDA premarket approval P160014 · decided 2017-02-21
Approval details
- PMA number
- P160014
- Trade name
- COBRA PzF NanoCoated Coronary Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Celonova Biosciences, Inc.
- Date received
- 2016-05-02
- Decision date
- 2017-02-21
- Days to decision
- 295 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Antonio, TX
- Statement
- Approval for the COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to do novo lesions in native coronary arteries. The COBRA PzF Stent System is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.5-4.0 mm and lesion length of <24 mm.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES (K141209) | Celonova Biosciences, Inc. | 2014-08-07 |
| EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (K133447) | Celonova Biosciences, Inc. | 2014-02-24 |
| EMBOZENE MICROSPHERES (K132675) | Celonova Biosciences, Inc. | 2013-10-03 |
| ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE (K130307) | Celonova Biosciences, Inc. | 2013-03-04 |
| EMBOZENE MICROSPHERES (K073417) | Celonova Biosciences, Inc. | 2008-12-15 |