Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor

FDA premarket approval P150004/S063 · decided 2023-12-19

Approval details

PMA number

P150004

Supplement

S063

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2023-06-23

Decision date

2023-12-19

Days to decision

179 days

Decision code

APPR

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

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.

510(k) clearances by this applicant