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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.
 
DeviceMODEL 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 Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
minneapolis, MN 55432
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/instructions/shelf life/tradename
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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