| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C |
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| Generic Name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
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| Applicant | Farapulse, Inc.
3715 Haven Ave.
Suite 110
Menlo Park, CA 94025 |
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| PMA Number | P230030 |
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| Supplement Number | S007 |
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| Date Received | 11/25/2024 |
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| Decision Date | 07/03/2025 |
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| Product Code |
QZI |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT04612244
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
approval for the FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Mapping System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Y-Cable Long, FARASTAR™ Stimulation Module Y-Cable Short, FARASTAR™ Recording System Module Catheter Pin Cable, FARASTAR™ Recording System Module ECG Trunk Cable, FARASTAR™ Recording System Module ECG Output Module (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI), FARASTAR™ SNAP CABLE C SET – (IEC), FARASTAR™ Recording System Module ECG Output to Rhythmia HDx™ ECG Input Cable, FARASTAR™ Recording System Module EGM Output to Rhythmia HDx™ EGM Input Cable, FARASTAR™ Mapping System Module Back Patch Cable, FARASTAR™ Mapping System Module Back Patch Cable Male, FARASTAR™ Mapping System Module BNC BNC-Phono Cable, FARASTAR™ Mapping System Module Rhythmia™ ABL Cable, FARASTAR™ Mapping System Module Auxiliary Cable) for expanding the indications to include the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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