PMA P150004S063

Device: Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S063
Product code: PMP
Decision date: 2023-12-19
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval for expanded 1.5T MR conditional labeling to allow full-body scanning using integrated whole-body RF coils with any receive coil for the Proclaim DRG IPG (Model 3664) when implanted with the DRG 50cm leads (models MN10450-50, MN10450-50A) and associated implantable accessories including the port plug (Model 7108) and lead anchor.

Current openFDA PMA Record#

Device: Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S063
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2023-12-19
Decision code: APPR
Date received: 2023-06-23
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanded 1.5T MR conditional labeling to allow full-body scanning using integrated whole-body RF coils with any receive coil for the Proclaim DRG IPG (Model 3664) when implanted with the DRG 50cm leads (models MN10450-50, MN10450-50A) and associated implantable accessories including the port plug (Model 7108) and lead anchor.