PMA P160025S023
- Device
- Astron Pulsar; Pulsar-18; Pulsar-18 T3
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S023
- Product code
- NIP
- Decision date
- 2025-12-17
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- new hydrogen content testing equipment
Current openFDA PMA Record#
- Device
- Astron Pulsar; Pulsar-18; Pulsar-18 T3
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S023
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new hydrogen content testing equipment