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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.
 
DeviceFamily of DBS IPGs
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS095
Date Received03/29/2024
Decision Date06/26/2024
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
Approval for: • Version 4.00 of the Patient Controller Application to be run on the Android OS that combines the two Patient Controller Applications approved in P010032/S187 (Patient Controller Application version 3.11) and P010032/S202 (Patient Controller Application version 2.00). • Predetermined Change Control Plan (PCCP) of the Patient Controller Application version 4.00 to be run on the Apple iOS.
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