PMA P160003S018
- Device
- PRO-KINETIC ENERGY CORONARY STENT SYSTEM
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S018
- Product code
- MAF
- Decision date
- 2023-08-16
- Classification
- Cardiovascular
- Generic name
- STENT, CORONARY
- Approval order statement
- Introduction of new shrink tubes for the welding process of delivery system components and laser welding equipment.
Current openFDA PMA Record#
- Device
- PRO-KINETIC ENERGY CORONARY STENT SYSTEM
- Applicant
- Biotronik AG
- PMA number
- P160003
- Supplement
- S018
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2023-08-16
- Decision code
- OK30
- Date received
- 2023-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of new shrink tubes for the welding process of delivery system components and laser welding equipment.