PMA P150004S095

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S095
Product code: PMP
Decision date: 2026-06-30
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: updated design verification testing, including fluid ingress evaluations, for the Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generators (IPG) header seals that were approved under P150004/S052.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S095
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2026-06-30
Decision code: APPR
Date received: 2026-04-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: updated design verification testing, including fluid ingress evaluations, for the Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generators (IPG) header seals that were approved under P150004/S052.