DevicePMAs@therightstef:P950037_S079 / 104-111 JSONTXT

Approval for a stand-alone version of the pacing system analyzer function found in the ics 3000 implant control system. The device, as modified, will be marketed under the trade name reliaty by biotronik, inc. and model 3145 by boston scientific and is indicated for use in pacing lead system analysis during the implantation of pacemakers and defibrillators.

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PMA_MER 1 (1)