PMA P160014S017
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S017
- Product code
- MAF
- Decision date
- 2020-11-19
- Generic name
- STENT, CORONARY
- Approval order statement
- Modifications to the laser and folding equipment, crimp recipe, and coating solution testing.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S017
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2020-11-19
- Decision code
- OK30
- Date received
- 2020-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the laser and folding equipment, crimp recipe, and coating solution testing.