PMA P160003S021
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S021
- Product code
- MAF
- Decision date
- 2024-05-17
- Classification
- Cardiovascular
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for an additional visual inspection at Biotronik AG and Biotronik APM and work instruction consolidation at Biotronik AG.
Current openFDA PMA Record#
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S021
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2024-05-17
- Decision code
- APPR
- Date received
- 2024-04-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional visual inspection at Biotronik AG and Biotronik APM and work instruction consolidation at Biotronik AG.