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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS052
Date Received04/10/2001
Decision Date08/03/2001
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the indications for use from "chronic intractable pain of the trunk or limbs" to "chronic intractable pain of the trunk and/or limbs". The indication statement has been revised to state "the medtronic [trade name] system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (ddd)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (crps) or reflex sympathetic dystrophy (rsd) or causalgia. ".
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