PMA P160025S014
- Device
- Pulsar-18 Stent Systems
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S014
- Product code
- NIP
- Decision date
- 2022-05-20
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Increase in laser cutting speed.
Current openFDA PMA Record#
- Device
- Pulsar-18 Stent Systems
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S014
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-05-20
- Decision code
- OK30
- Date received
- 2022-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase in laser cutting speed.