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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP150005
Supplement NumberS074
Date Received02/03/2023
Decision Date02/26/2024
Product Codes OAD OAE 
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping SystemThe INTELLANAV STABLEPOINT Catheter, when used with a compatible Radiofrequency Controller and IrrigationPump, is indicated for:• Cardiac electrophysiological mapping• Delivering diagnostic pacing stimuli• RF ablation of sustained or recurrent typical atrial flutter in patients age 18 years or older• Treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
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