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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 EXTENSION MODELS 37081, 37082 AND 37083
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS221
Date Received07/16/2012
Decision Date09/14/2012
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR MODIFICATIONS TO THE PACKAGE DIMENSIONS, THE INNER TRAY AND THE RETAINER LID. ALSO REQUESTED WAS A PACKAGE MATERIAL CHANGE FROM POLYVINYL CHLORIDE (PVC) TO POLYETHYLENE TEREPHTHALATE GLYCOL (PETG) FOR THE OUTER TRAY, THE INNER TRAY AND THE RETAINER LID.
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