PMA P150004S057

Device: Proclaim DRG Systems
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S057
Product code: PMP
Decision date: 2022-08-19
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval for version 3.11 of the Clinician Programmer and Patient Controller applications which merge previously approved software features into a single version and include minor enhancements and administrative updates. In addition, approval for four new Proclaim SCS Implantable Pulse Generator (IPG) models (models 3670, 3671, 3672, and 3673).

Current openFDA PMA Record#

Device: Proclaim DRG Systems
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S057
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2022-08-19
Decision code: APPR
Date received: 2022-05-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for version 3.11 of the Clinician Programmer and Patient Controller applications which merge previously approved software features into a single version and include minor enhancements and administrative updates. In addition, approval for four new Proclaim SCS Implantable Pulse Generator (IPG) models (models 3670, 3671, 3672, and 3673).