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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.
 
DeviceRestore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS488
Date Received05/17/2021
Decision Date08/12/2021
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design change to the Recharger Therapy Manager (RTM) model 97755, to modify the interface between the antenna and the cable, to include an additional strain relief. This strain relief at the antenna-cable interface will include an elongated antenna section that is overmolded with a strain relief at the antenna-cable interface. Additionally, RTM cable length specification changes from 37 ± 1 inches to 35.4 ± 2 inches and the Crimp Ferrule minimum pull force strength will be increased from 3 lbs. minimum to 4.2 lbs.
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