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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceALGOVITA SPINAL CORD STIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNuvectra Corporation
10675 NAPLES STREET NE
BLAINE, MN 55449
PMA NumberP130028
Date Received12/16/2013
Decision Date11/20/2015
Product Code LGW 
Docket Number 15M-4434
Notice Date 11/30/2015
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ALGOVITA SPINAL CORD STIMULATION SYSTEM. THIS DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S002 S006 S007 S008 S011 S012 S013 S001 S003 S004 S005 
S018 S009 S010 S014 S015 S016 S017 S024 S025 S027 S028 S029 
S023 S021 S020 S022 S030 S031 S026 
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