GENESIS NEUROSTIMULATION (IPG) SYSTEM

FDA premarket approval P010032/S013 · decided 2005-05-11

Approval details

PMA number

P010032

Supplement

S013

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS NEUROSTIMULATION (IPG) SYSTEM

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2004-12-16

Decision date

2005-05-11

Days to decision

146 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR THE ADDITION OF FOUR MODELS OF THE S-SERIES LAMITRODE LEADS AS ACCESSORIES TO THE GENESIS FAMILY OF NEUROSTIMULATION IPG DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S-SERIES LAMITRODE LEADS (MODEL NUMBERS3243, 3246, 3283 AND 3286) AND IS INDICATED FOR USE AS THE LEAD COMPONENT OF A SPINAL CORD STIMULATION SYSTEM. THE SPINAL CORD STIMULATION SYSTEM IS USED TO AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR EXTREMITIES.

510(k) clearances by this applicant