PMA P160025S011
- Device
- Astron Pulsar Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S011
- Product code
- NIP
- Decision date
- 2021-05-06
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Modification to the ethylene oxide sterilization parameters.
Current openFDA PMA Record#
- Device
- Astron Pulsar Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S011
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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.