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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter remote control system
Definition A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
Product CodePJB
Regulation Number 870.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 2 2
Mechanical Problem 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stereotaxis Inc II Nov-06-2020
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