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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 NameSYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS082
Date Received09/07/2005
Decision Date11/04/2005
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3776 1x8 sc (subcompact) low impedance lead kit and the model 3876 1x8 sc low impedance lead kit.
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