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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS221
Date Received07/17/2012
Decision Date09/14/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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