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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.
 
DeviceSPINAL CORD STIMULATION
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS105
Date Received12/21/2007
Decision Date01/17/2008
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
USE OF AN INSERT-MOLDED PROCESS TO MANUFACTURE THE BOND PAD ARRAY (BPA) IN PLACE OF A PRESS-FIT MANUFACTURING METHOD.
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