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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.
 
DeviceDEEP BRAIN STIMULATION (DBS) LEADS
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS135
Date Received12/16/2011
Decision Date01/13/2012
Product Code MHY 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
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