|
Device | ASSURE Wearable Cardioverter Defibrillator (WCD) System |
Generic Name | Wearable automated external defibrillator |
Applicant | Kestra Medical Technologies, Inc. 3933 Lake Washington Boulevard, N.E. Suite 200 Kirkland, WA 98033 |
PMA Number | P200037 |
Date Received | 08/13/2020 |
Decision Date | 07/27/2021 |
Product Code |
MVK |
Docket Number | 21M-0820 |
Notice Date | 07/29/2021 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03887052
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the ASSURE system which is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S004 S001 S002 S005 S008 S006 S007 S010 S003 S009 |