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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.
 
DeviceSPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS308
Date Received06/19/2015
Decision Date02/05/2016
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Specify SureScan MRI 5-6-5 and 2x8 surgical lead kits.
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