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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.
 
DeviceMODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS144
Date Received04/30/2012
Decision Date05/30/2012
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS.
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