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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.
 
DeviceIMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS169
Date Received03/18/2013
Decision Date06/22/2015
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A LABELING UPDATE THAT MODIFIES YOUR DEEP BRAIN STIMULATION (DBS) THERAPY INFORMATION FOR PRESCRIBER¿S AND THE DBS PATIENT THERAPY GUIDE. THE LABELING UPDATE IS TO MODIFY TWO PRECAUTIONS THAT APPEAR IN EACH MANUAL:1) REMOVE THE PRECAUTION ON POTENTIAL RELEASE OF NEUROTOXIC AND CARCINOGENIC COMPOUNDS FROM POLYURETHANE LEAD MATERIALS; AND2) MODIFY THE PRECAUTION ON LONG-TERM SAFETY OF MULTIPLE LEADS AND REPLACEMENT LEADS TO READ: THE LONG-TERM SAFETY ASSOCIATED WITH IMPLANTING MORE THAN ONE LEAD ON THE SAME SIDE OF THE BRAIN IS UNKNOWN.
Post-Approval StudyShow Report Schedule and Study Progress
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