PMA P230030
- Device
- FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)
- Applicant
- Farapulse, Inc.
- Product code
- QZI
- Decision date
- 2026-07-10
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- two manufacturing changes to be implemented at the supplier
Current openFDA PMA Record#
- Device
- FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)
- Applicant
- Farapulse, Inc.
- PMA number
- P230030
- Supplement
- S022
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-07-10
- Decision code
- OK30
- Date received
- 2026-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- two manufacturing changes to be implemented at the supplier