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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, SYNERGY, SYNERGY VERSITREL, ITREL 4
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS228
Date Received09/25/2012
Decision Date10/24/2012
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 
Manufacture of one inner seal silicone component at the alternate supplier, flexan located in suzhou industrial park, china.
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