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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.
 
DeviceDBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS182
Date Received09/23/2013
Decision Date10/22/2013
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
Post-Approval StudyShow Report Schedule and Study Progress
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