|
Device | DUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S042 |
Date Received | 10/01/1998 |
Decision Date | 11/19/1999 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Dual Chamber Intrel(R) Synergy(TM) Neurostimulation System as well as the Model 7459 MemoryMod Software for use with the existing Itrel(R) 3 Spinal cord Stimulation System. |