PMA P150004S080

Device: NeuroSphere Digital Health Apps
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S080
Product code: PMP
Decision date: 2024-12-20
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval for updating the NeuroSphereTM Clinical Programmer (CP) and NeuroSphereTM Patient Controller (PC) applications from version 2.0.2 to version 2.0.3 and the NeuroSphereTM Digital Health App (OneApp) from version 4.0 to version 4.0.1.

Current openFDA PMA Record#

Device: NeuroSphere Digital Health Apps
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S080
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-12-20
Decision code: APPR
Date received: 2024-10-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for updating the NeuroSphereTM Clinical Programmer (CP) and NeuroSphereTM Patient Controller (PC) applications from version 2.0.2 to version 2.0.3 and the NeuroSphereTM Digital Health App (OneApp) from version 4.0 to version 4.0.1.