PMA P160014S001
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S001
- Product code
- MAF
- Decision date
- 2018-04-16
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Change to an in-process inspection step in the manufacturing process for the COBRA PzF NanoCoated Coronary Stent System.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S001
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2018-04-16
- Decision code
- OK30
- Date received
- 2018-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to an in-process inspection step in the manufacturing process for the COBRA PzF NanoCoated Coronary Stent System.