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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 Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS220
Date Received02/27/2015
Decision Date05/11/2015
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MATERIAL CHANGES TO TWO NON-IMPLANTABLE SCREENING CABLES (THE ALLIGATOR CLIP SCREENING CABLE ACCESSORY KIT AND THE TWIST LOCK SCREENING CABLE ACCESSORY KIT) TO COMPLY WITH THE EUROPEAN UNION RESTRICTION OF HAZARDOUS SUBSTANCES II DIRECTIVE 2011/65/EU.
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