Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | GENESIS NEUROSTIMULATION (IPG) SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S013 |
Date Received | 12/16/2004 |
Decision Date | 05/11/2005 |
Product Codes |
GZB LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |
|
|