PMA P150004S071

Device: Family of DRG IPGs
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S071
Product code: PMP
Decision date: 2024-06-26
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval for: • Version 4.00 of the Patient Controller Application to be run on the Android OS that combines the two Patient Controller Applications approved in P010032/S187 (Patient Controller Application version 3.11) and P010032/S202 (Patient Controller Application version 2.00). • Predetermined Change Control Plan (PCCP) of the Patient Controller Application version 4.00 to be run on the Apple iOS.

Current openFDA PMA Record#

Device: Family of DRG IPGs
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S071
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-06-26
Decision code: APPR
Date received: 2024-03-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for: • Version 4.00 of the Patient Controller Application to be run on the Android OS that combines the two Patient Controller Applications approved in P010032/S187 (Patient Controller Application version 3.11) and P010032/S202 (Patient Controller Application version 2.00). • Predetermined Change Control Plan (PCCP) of the Patient Controller Application version 4.00 to be run on the Apple iOS.