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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 PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREULTRA, RESTOREADVANCED RECHARGEABLE
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS131
Date Received02/23/2009
Decision Date04/20/2009
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 74001 (1x4) pocket adaptor and model 74002 (2x4) pocket adaptor.
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