Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Death, Heart Failure, Septal Myectomy, and Ventricular Arrhythmia

Basic Details
Status
Ongoing
Last Updated
Thursday, September 17, 2020
Original Posting Date
Health Outcome(s)
atrioventricular block
death
heart failure
septal myectomy
ventricular arrhythmia
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
Yes
Result(s) (1)
Frequency of Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) and Estimated Incidence Rates of Post-PTSMA Cardiovascular Outcomes: A Descriptive Analysis
Regulatory Link(s) (1)
Approval Letter
Related Publication(s) and/or Presentation(s) (1)
Presentation: Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications: A Descriptive Study
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