PMA P160003S014
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S014
- Product code
- MAF
- Decision date
- 2021-07-13
- Generic name
- STENT, CORONARY
- Approval order statement
- Source change for an acid solution used during the stent manufacturing.
Current openFDA PMA Record#
- Device
- PRO-Kinetic Energy Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S014
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2021-07-13
- Decision code
- OK30
- Date received
- 2021-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Source change for an acid solution used during the stent manufacturing.