PMA P140030S013
- Device
- Astron Peripheral Self- Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S013
- Product code
- NIO
- Decision date
- 2021-05-06
- Generic name
- STENT, ILIAC
- Approval order statement
- Modification to the ethylene oxide sterilization parameters.
Current openFDA PMA Record#
- Device
- Astron Peripheral Self- Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S013
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-05-06
- Decision code
- OK30
- Date received
- 2021-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the ethylene oxide sterilization parameters.