PMA P160014S006
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S006
- Product code
- MAF
- Decision date
- 2019-03-15
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for a new crimping/pillowing process.
Current openFDA PMA Record#
- Device
- COBRA PzF NanoCoated Coronary Stent System
- Applicant
- Celonova Biosciences, Inc.
- PMA number
- P160014
- Supplement
- S006
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2019-03-15
- Decision code
- APPR
- Date received
- 2018-10-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new crimping/pillowing process.