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- Page 2

# FdaApprovalPulse: records in Minnesota, page 2 of 2

Records 51 to 61 of the 61 newest listed for this hub. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

[1](/hub/fdaapprovalpulse/state/mn) 2

| Record | Product | Approval | Decided |
|---|---|---|---|
| Medtronic, Inc. | Affera Ablation System | PMA supplement (device change) | 2026-05-28 |
| Medtronic Cardiac Rhythm Disease Management | SelectSecure Lead Model 3830 | PMA supplement (device change) | 2026-05-28 |
| Envoy Medical Corporation | Esteem® | PMA supplement (device change) | 2026-05-21 |
| Medtronic, Inc. | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | PMA supplement (device change) | 2026-05-20 |
| Boston Scientific Corp | WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure | PMA supplement (device change) | 2026-05-18 |
| Medtronic, Inc. | Sphere-9 Catheter and Affera Ablation System | PMA supplement (device change) | 2026-05-15 |
| Medtronic, Inc. | Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar | PMA supplement (device change) | 2026-05-14 |
| Medtronic, Inc. | Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur | PMA supplement (device change) | 2026-05-14 |
| Medtronic, Inc. | CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos | PMA supplement (device change) | 2026-05-06 |
| Medtronic, Inc. | CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014) | PMA supplement (device change) | 2026-05-06 |
| Boston Scientific Corporation | Ranger™ Paclitaxel-Coated PTA Balloon Catheter | PMA supplement (device change) | 2026-05-01 |

[1](/hub/fdaapprovalpulse/state/mn) 2

[All FdaApprovalPulse record reports](/hub/fdaapprovalpulse/records)

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