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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 RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS225
Date Received08/14/2012
Decision Date09/12/2012
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 No
Approval Order Statement 
Change the acceptance criteria for titanium content in the cables and to add an alternate supplier for the cable braiding and micro-extrusion processes.
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