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  6. INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System - P150005/S074
  1. Recently-Approved Devices

INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System - P150005/S074

INTELLANAV STABLEPOINT Ablation Catheter uses radiofrequency (RF) energy applied by the catheter tip to destroy heart tissue cells that are causing heart rhythm problems

 


This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System
PMA Applicant: Boston Scientific Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN 55112, USA
Approval Date: 02/26/2024
Approval Letter: Approval Order

What is it?

The INTELLANAV STABLEPOINT Ablation Catheter uses radiofrequency (RF) energy applied by the catheter tip to destroy heart tissue cells that are causing heart rhythm problems (arrhythmias).

 
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