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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.
 
DeviceProclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS125
Date Received10/24/2016
Decision Date07/21/2017
Product Code LGW 
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 AuthorizedNo
Approval Order Statement  
Approval for 1) Addition of a Proclaim IPG device models 3661 and 3663, each with a header that is compatible with Medtronic (MDT) leads; 2) Sustaining enhancements to the firmware (FW 1.1 – new version of firmware; 3) Enabling the Burst stimulation feature (marketed as BurstDR stimulation) for Proclaim IPGs with MDT headers and 4) Inclusion of the Lead & Extension Insertion Tool (LEIT).
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