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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 NumberS230
Date Received05/28/2015
Decision Date06/26/2015
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE USER MANUAL FOR THE IMPLANTABLE NEUROSTIMULATOR RECHARGING SYSTEMS; SPECIFICALLY, THE ADDITION OF A WARNING STATEMENT FOR THE ANTENNA LOCATE FEATURE, AS WELL AS INSTRUCTIONS FOR EXITING THIS FEATURE, AND DIRECTIONS TO CONTACT MEDTRONIC IF THE PATIENT ENCOUNTERS ANY PROBLEMS.
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