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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.
 
DeviceActiva Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS255
Date Received06/27/2016
Decision Date07/27/2016
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
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