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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 (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS212
Date Received04/10/2012
Decision Date05/10/2012
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 Yes
Approval Order Statement 
Changes in the manufacturing process at medtronic¿s supplier of grommets used in various medtronic neuromodulation implantable devices.
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