PMA P140030S022
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S022
- Product code
- NIO
- Decision date
- 2025-12-17
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- new hydrogen content testing equipment
Current openFDA PMA Record#
- Device
- Astron
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S022
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new hydrogen content testing equipment