PMA supplement
P240013 S012: Sphere-9 Catheter and Affera Ablation System (HexaFlow™ Irrigation Pump; HexaGen™ RF Generator; HexaPulse™ PF Generator)
FDA PMA supplement · 30-Day Notice · Medtronic, Inc.
Key facts
| Original PMA | P240013 |
|---|---|
| Supplement number | S012 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Sphere-9 Catheter and Affera Ablation System (HexaFlow™ Irrigation Pump; HexaGen™ RF Generator; HexaPulse™ PF Generator) |
| Generic name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
| Applicant | Medtronic, Inc. |
| Product code | QZI |
| Received date | Jun 23, 2025 |
| Decision date | Jul 22, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: