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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 NumberS489
Date Received05/27/2021
Decision Date08/25/2021
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 1) design changes to add an alternative glassed feedthrough assembly component which has the same fit, form and function, to the current brazed feedthrough assembly component in the Model 97715 and Model 97716 Intellis Implantable Neurostimulators, and 2) manufacturing changes to include a new chemical treatment step (i.e., Nitric/HF acid) to clean the titanium array plate (A distilled water rinse step will be added after the new chemical treatment step to remove any residual chemicals from the feedthrough).
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