PMA P150004S072

Device: Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S072
Product code: PMP
Decision date: 2024-05-16
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: to replace the microcontroller chip on the printed circuit board of the External Pulse Generator (EPG) base

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S072
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-05-16
Decision code: OK30
Date received: 2024-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to replace the microcontroller chip on the printed circuit board of the External Pulse Generator (EPG) base