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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.
 
DeviceNEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS267
Date Received03/31/2014
Decision Date04/30/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
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