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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 NameRESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP840001
Supplement NumberS113
Date Received05/16/2008
Decision Date06/10/2008
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add a new component vendor to supply two integrated circuits (ics) for use on the hybrids in the restore family of devices.
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