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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 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.
 
DeviceMODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS052
Date Received04/10/2001
Decision Date08/03/2001
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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