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Device | Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S125 |
Date Received | 10/24/2016 |
Decision Date | 07/21/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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). |