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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) Implantable Pulse Generator (IPG)
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS130
Date Received03/27/2026
Decision Date04/25/2026
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
incorporate an additional inspection step to provide enhanced assurance of device reliability and safety; this change adds a manufacturing functional test to verify Bluetooth Low Energy (BLE) communication functionality of devices prior to distribution
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