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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 NameITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY/SYNERGY VERSITREL/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS187
Date Received05/20/2011
Decision Date06/17/2011
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an ethylene oxide sterilizer system.
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