SlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit

FDA premarket approval P150004/S026 · decided 2018-12-03

Approval details

PMA number

P150004

Supplement

S026

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2018-09-04

Decision date

2018-12-03

Days to decision

90 days

Decision code

APPR

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for minor design changes for the Doral Root Ganglion (DRG) Leads and Extensions: a) increasing proximal terminal electrode spacing tolerance from +0.010 to +0.012 on the DRG leads and extension; and b) increasing balseal spacing tolerance from +0.010 to +0.013 on the DRG extension header and center the nominal spacing dimensions to the center of the balseal.

510(k) clearances by this applicant