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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 NameMEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS095
Date Received12/29/2006
Decision Date03/07/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor design change to the feedthrough and for the use of acetone for the removal and replacement of the connector block in the manufacturing rework process.
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