PMA P140030S008
- Device
- Astron Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S008
- Product code
- NIO
- Decision date
- 2018-10-15
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Changing a stent component laser cutting process parameter.
Current openFDA PMA Record#
- Device
- Astron Stent System
- Applicant
- Biotronik AG
- PMA number
- P140030
- Supplement
- S008
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2018-10-15
- Decision code
- OK30
- Date received
- 2018-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changing a stent component laser cutting process parameter.