PMA P140030S014
- Device
- Astron Peripheral Self-Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S014
- Product code
- NIO
- Decision date
- 2021-10-14
- Generic name
- STENT, ILIAC
- Approval order statement
- Modifications to the ultrasonic pre-cleaning process and replacement of the ultrasonic cleaning machine.
Current openFDA PMA Record#
- Device
- Astron Peripheral Self-Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S014
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-10-14
- Decision code
- OK30
- Date received
- 2021-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the ultrasonic pre-cleaning process and replacement of the ultrasonic cleaning machine.