GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

FDA premarket approval P010032/S092 · decided 2015-07-09

Approval details

PMA number

P010032

Supplement

S092

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2014-12-19

Decision date

2015-07-09

Days to decision

202 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR THE ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM COMPRISING OF THE FOLLOWING DEVICES:1) ST. JUDE MEDICAL EXTERNAL PULSE GENERATOR (EPG), 16 CHANNEL: MODEL 3599; 2) ST. JUDE MEDICAL CLINICIAN PROGRAMMER APP (CP): MODEL 3870;3) ST. JUDE MEDICAL PATIENT CONTROLLER APP (PC): MODEL 3871; AND 4) ASSOCIATED ACCESSORIES (LEAD MODELS 3046, 3066, AND 3086 AND MULTI-LEAD TRIAL CABLE (MLTC) 3013).THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM A

510(k) clearances by this applicant