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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.
 
DeviceRESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS195
Date Received07/29/2011
Decision Date08/26/2011
Product Code LGW 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION. THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
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