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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, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS310
Date Received08/07/2015
Decision Date09/04/2015
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ACCEPT A NEW HARD STOP AND UPPER ARM IMPLEMENTATION FOR THE CRIMPERS USED DURING THE SLEEVE TO WIRE ASSEMBLY OF THE SPINAL CORD STIMULATION LEADS.
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