PMA P160003S017
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S017
- Product code
- MAF
- Decision date
- 2023-08-07
- Classification
- Cardiovascular
- Generic name
- STENT, CORONARY
- Approval order statement
- Implementing an additional bioindicator to prepare the external process challenge devices for routine release.
Current openFDA PMA Record#
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S017
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2023-08-07
- Decision code
- OK30
- Date received
- 2023-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing an additional bioindicator to prepare the external process challenge devices for routine release.