PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG

FDA premarket approval P010032/S109 · decided 2016-10-03

Approval details

PMA number

P010032

Supplement

S109

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2015-12-11

Decision date

2016-10-03

Days to decision

297 days

Decision code

APPR

Product code

LGW

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, and the Protégé/Prodigy/Proclaim Elite family of SCS IPGs and SCS EPG 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 Model 3834 (Version 3.7

510(k) clearances by this applicant