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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.
 
DeviceSURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS219
Date Received07/03/2012
Decision Date03/20/2013
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 OF THE MEDTRONIC SURESCANTM MRI IMPLANTABLE NEUROSTIMULATION SYSTEM, WHICH CONSISTS OF THE PRIMEADVANCED SURESCAN¿ MRI IPG MODEL 97702; RESTOREULTRA SURESCAN¿ MRI IPG MODEL 97712; RESTOREADVANCED SURESCAN¿ MRI IPG MODEL 97713;RESTORESENSOR SURESCAN¿ MRI IPG MODEL 97714; VECTRIS SURESCANTM MRI 1X8 SUBCOMPACT LEADS MODELS 977A160, 977A175, AND 977A190; VECTRIS SURESCANTM MRI 1X8 COMPACT LEADS MODELS 977A260, 977A275, AND 977A290; VECTRIS 1X8 SUBCOMPACT TRIALING LEAD MODEL977D160; VECTRIS 1X8 COMPACT TRIALING LEAD MODEL 977D260; PATIENT PROGRAMMER MODEL 97740; PATIENT RECHARGER KIT MODEL 97754; N¿VISION APPLICATION CARD, VERSION AAP01 MODEL 8870; CLINICIAN PROGRAMMER MODEL 8840; EXTERNAL ANTENNA MODEL 37092; EXTERNALNEUROSTIMULATOR MODEL 37022; AND EXTERNAL NEUROSTIMULATOR MODEL 37021. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC SURESCAN¿ MRI IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED AS FOLLOWS.THE MEDTRONIC SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITHTHE FOLLOWING:1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK;2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILEDBACK SYNDROME;3) POST LAMMECTOMY PAIN;4) UNSUCCESSFUL DISK SURGERY;5) DEGENERATIVE DISK DISEASE (DDD)/ HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS;6)PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS;8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS;9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK OPERATIONS.
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