PMA P160003S019
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S019
- Product code
- MAF
- Decision date
- 2024-03-26
- Classification
- Cardiovascular
- Generic name
- STENT, CORONARY
- Approval order statement
- the removal of redundant in-process inspection for the stent surface
Current openFDA PMA Record#
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S019
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2024-03-26
- Decision code
- OK30
- Date received
- 2024-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the removal of redundant in-process inspection for the stent surface