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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 Deep Brain Stimulation (DBS) System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024
PMA NumberP140009
Supplement NumberS050
Date Received08/09/2019
Decision Date09/05/2019
Product Codes MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Changes Being Effected (CBE) for the Infinity Deep Brain Stimulation System. The changes being effected include: 1) Changes to DBS System physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type; and2) A minor change to the Program Storage Capacity Section of the Infinity IPG Clinicians Manual to updated from 15 programs with 1 stim set per lead to 15 programs to reflect the addition of the MultiStim feature.
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