PulseSelect Pulsed Field Ablation (PFA) system
FDA premarket approval P230017/S001 · decided 2024-06-18
Approval details
- PMA number
- P230017
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PulseSelect Pulsed Field Ablation (PFA) system
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Medtronic, Inc.
- Date received
- 2024-01-11
- Decision date
- 2024-06-18
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval of the for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230017
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