PMA P160014S002
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S002
- Product code
- MAF
- Decision date
- 2018-07-12
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Change to the manufacturer of the adhesion promoter used in the coating process of the COBRA PzF stent.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S002
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2018-07-12
- Decision code
- OK30
- Date received
- 2018-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturer of the adhesion promoter used in the coating process of the COBRA PzF stent.