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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 TREMOR CONTROL THERAPY SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS020
Date Received07/10/2001
Decision Date08/10/2001
Product Code MHY 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ADDITIONAL QUALITY CONTOROL PROCESS STEP TO VERIFY THAT NEUROSTIMULATORS ARE MANUFACTURED TO THEIR SPECIFICATION, E.G., THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM CASE (SHIELD).
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