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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantST. JUDE MEDICAL
PMA NumberP140009
Supplement NumberS003
Date Received08/14/2015
Decision Date09/10/2015
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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