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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceITREL 3 SYNERGY AND SYNERGY VERITREL SPINAL CORD STIMULATION SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS073
Date Received05/19/2004
Decision Date06/16/2004
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW PERMANENTLY IMPLANTED SURGICAL LEAD (MODEL 3999 HINGED 2 X 4 LEAD) TO BE USED WITH MEDTRONICS FULLY IMPLANTABLE NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (P840001) OR THE EXTERNAL RADIO FREQUENCY NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (K934065).
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