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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, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS469
Date Received08/10/2021
Decision Date01/21/2022
Product Codes LGW QRB 
Docket Number 22M-0089
Notice Date 01/25/2022
Advisory Committee Neurology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indications to include the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, due to diabetic peripheral neuropathy of the lower extremities.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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