Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit

FDA premarket approval P150004/S068 · decided 2024-01-10

Approval details

PMA number

P150004

Supplement

S068

Supplement type

Real-Time Process

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2023-10-13

Decision date

2024-01-10

Days to decision

89 days

Decision code

APPR

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

for a minor packaging configuration change to the Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit.

510(k) clearances by this applicant