PMA P160014S003
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S003
- Product code
- MAF
- Decision date
- 2018-11-14
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for changes to the materials used in the inner member of the delivery system.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S003
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2018-11-14
- Decision code
- APPR
- Date received
- 2018-08-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the materials used in the inner member of the delivery system.