- Device
- FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)
- Applicant
- Farapulse, Inc.
- PMA number
- P230030
- Supplement
- S017
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-01-13
- Decision code
- OK30
- Date received
- 2025-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a supplier consolidation for the punched strut manufacturing process