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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.
 
DeviceSPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS003
Date Received08/14/2015
Decision Date09/10/2015
Product Codes MHY NHL 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ACCEPTANCE OF REPLACING AN EXISTING CENTERLESS GRINDER (GLEBAR TF-9DHD) WITH A NEW CENTERLESS GRINDER (GLEBAR GT-9DHD) USED DURING THE MANUFACTURING OF SCS LEADS, DBS LEADS, AND TERMINAL END SUBASSEMBLIES.
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