PMA P160025S026
- Device
- Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S026
- Product code
- NIP
- Decision date
- 2026-09-11
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- modifications to the Gold-plating manufacturing equipment
Current openFDA PMA Record#
- Device
- Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S026
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-09-11
- Decision code
- OK30
- Date received
- 2026-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to the Gold-plating manufacturing equipment