PMA P160014
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S018
- Product code
- MAF
- Decision date
- 2021-10-12
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for the updated final labeling to reflect the 5-year data obtained in the PzF SHIELD PAS study.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S018
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2021-10-12
- Decision code
- APPR
- Date received
- 2021-05-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the updated final labeling to reflect the 5-year data obtained in the PzF SHIELD PAS study.