DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS

FDA premarket approval P140009/S015 · decided 2016-11-28

Approval details

PMA number

P140009

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2016-06-06

Decision date

2016-11-28

Days to decision

175 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval of the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664 Proclaim DRG IPG7108 Port PlugMN15000 Tunneling Tool KitNot applicable Torque WrenchNot applicable Pocket SizerMN10450-50 Implant Lead Kit, 50cmMN10450-50A Implant Lead Kit, SlimTip, 50cmNot applicable Soft Tissue AnchorMN12050 Lead Accessory Kit3874 St. Jude Medical Clinician Programmer App3875 St

510(k) clearances by this applicant