PMA P160014S016
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S016
- Product code
- MAF
- Decision date
- 2020-04-27
- Generic name
- STENT, CORONARY
- Approval order statement
- Minor change to the manufacturing of a packaging component.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S016
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2020-04-27
- Decision code
- OK30
- Date received
- 2020-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor change to the manufacturing of a packaging component.