PMA P140030S018
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S018
- Product code
- NIO
- Decision date
- 2025-07-10
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- the introduction of a new hardware control logic unit for process ovens used in the manufacture of your coronary and peripheral stent systems
Current openFDA PMA Record#
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S018
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-07-10
- Decision code
- OK30
- Date received
- 2025-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of a new hardware control logic unit for process ovens used in the manufacture of your coronary and peripheral stent systems