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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 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS047
Date Received06/01/2000
Decision Date02/21/2001
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
Approval Order Statement  
APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE OF THE MEDTRONIC MODEL 7421 ITREL, 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION SYSTEMS. THESE DEVICES ARE NOW INDICATED "AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BCK 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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