INFINITY FAMILY OF DBS IPGS AND DBS EPG

FDA premarket approval P140009/S010 · decided 2016-10-03

Approval details

PMA number

P140009

Supplement

S010

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INFINITY FAMILY OF DBS IPGS AND DBS EPG

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2015-12-11

Decision date

2016-10-03

Days to decision

297 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for the Clinician Programmer App (Version 3.2) Model 3874, Programmer App (Version 3.2) Model 3875 (P140009), and the Protégé/Prodigy/Proclaim Elite family of SCS IPGs and SCS EPG (P010032) which includes the following components:1) IPGs: Protégé (Models 3789), Prodigy (Model 3799), Protégé MRI (Model 377l), Prodigy MRI (Model 3772), and Proclaim 5 Elite (Model 3660); 2) Proclaim 7 Elite (Model 3662) SCS EPG Model 3599; 3) Patient Programmer Models 3855 and 3856; 4) Rapid Programmer Mod

510(k) clearances by this applicant