DevicePMAs@therightstef:P820076_S021 / 255-259
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Approval for pacing system which includes a new single-pass VDD pacing lead, a pulse generator with high atrial sensitivity, and a new software module for use with the PMS 1000/1000C programmers. The device, as modified, will be marketed under the trade name Dromos SL Pacing System SWM 1000/F05.B00.U, and three versions of the single-pass lead, Models SL/11-BP, SL/13-BP and SL/15-BP. This pacing system is indicated for VDD pacing for patients with a healthy sinus node.
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projects
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