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Device | MEDTRONIC ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS |
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 | S051 |
Date Received | 02/01/2001 |
Decision Date | 07/31/2001 |
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 APROVAL FOR THE MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION WHICH WILL BE USED WITH THE ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS. |