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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.
 
DeviceInfinity DBS IPG
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS139
Date Received06/29/2026
Decision Date09/23/2026
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a material change to the encapsulant used in the printed circuit board assembly (PCBA) during the manufacture of the Proclaim Spinal Cord Stimulator (SCS), Proclaim Dorsal Root Ganglion (DRG) stimulator and Infinity Deep Brain Stimulator (DBS) Implantable Pulse Generator (IPG) devices.
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