PMA P160025S013
- Device
- Pulsar-18 T3 Stent System
- Applicant
- Biotronik AG
- Product code
- NIP
- Decision date
- 2022-07-20
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for the Pulsar-18 T3 Stent System, which incorporates an updated delivery system to the Pulsar-18 Stent System.
Current openFDA PMA Record#
- Device
- Pulsar-18 T3 Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S013
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-07-20
- Decision code
- APPR
- Date received
- 2021-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Pulsar-18 T3 Stent System, which incorporates an updated delivery system to the Pulsar-18 Stent System.