COBRA PzF NanoCoated Coronary Stent System
FDA premarket approval P160014/S017 · decided 2020-11-19
Approval details
- PMA number
- P160014
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBRA PzF NanoCoated Coronary Stent System
- Generic name
- STENT, CORONARY
- Applicant
- Celonova Biosciences, Inc.
- Date received
- 2020-10-20
- Decision date
- 2020-11-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Antonio, TX
- Statement
- Modifications to the laser and folding equipment, crimp recipe, and coating solution testing.
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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 |