PMA P140030S021
- Device
- Astron Peripheral Self- Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S021
- Product code
- NIO
- Decision date
- 2025-10-21
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval to add a control step to verify the carton packaging material
Current openFDA PMA Record#
- Device
- Astron Peripheral Self- Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S021
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-10-21
- Decision code
- APPR
- Date received
- 2025-10-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add a control step to verify the carton packaging material