PMA P030005S176

Device

INVIVE CRT-P, INTUA CRT-P, VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P, and Programmer Softwa

Applicant

Guidant Corp.

PMA number

P030005

Supplement

S176

Product code

NKE

Decision date

2018-07-27

Classification

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)

Generic name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Approval order statement

Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.

Summary

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