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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.
 
DeviceDBS Extensions
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantAbbott Medical
6901 Prestion Road
Plano, TX 75024
PMA NumberP140009
Supplement NumberS025
Date Received06/26/2017
Decision Date07/24/2017
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
1) add a St. Jude Medical Facility located in Plymouth, MN as an alternate supplier for the extrusion and manufacture of the outer tubing and spacer components of the leads, extensions, and adapters; 2) adjust tolerances due to tighter process controls; and 3) implement the use of a visual measurement system for inspection.
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