AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG)
FDA premarket approval P240013/S008 · decided 2025-08-01
Approval details
- PMA number
- P240013
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG)
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Medtronic, Inc.
- Date received
- 2025-05-06
- Decision date
- 2025-08-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for hardware and firmware changes to the Affera Ablation System AFR-00008 HexaPulse PF Generator (PFG) and an enabling software change to the Affera Ablation System AFR-00004 HexaGen RF Generator (RFG)
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510(k) clearances by this applicant
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