ASSURE Wearable Cardioverter Defibrillator (WCD) System

FDA Premarket Approval P200037

Pre-market Approval Supplement Details

The assure system is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.

DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic NameWearable Automated External Defibrillator
ApplicantKestra Medical Technologies, Inc.
Date Received2020-08-13
Decision Date2021-07-27
PMAP200037
SupplementS
Product CodeMVK 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Kestra Medical Technologies, Inc. 3933 Lake Washington Boulevard, N.e. suite 200 kirkland, WA 98033
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P200037Original Filing
S006 2022-12-12 30-day Notice
S005 2022-09-28 30-day Notice
S004 2022-06-02 Normal 180 Day Track
S003 2021-11-17 30-day Notice
S002
S001 2021-09-15 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00840241600207 P200037 000
00840241600085 P200037 000
00840241600078 P200037 000
00840241600061 P200037 000
00840241600054 P200037 000
00840241600047 P200037 000
00840241600030 P200037 000
00840241600023 P200037 000
00840241600016 P200037 000
00840241600092 P200037 000
00840241600108 P200037 000
00840241600115 P200037 000
00840241600191 P200037 000
00840241600184 P200037 000
00840241600177 P200037 000
00840241600160 P200037 000
00840241600153 P200037 000
00840241600146 P200037 000
00840241600139 P200037 000
00840241600122 P200037 000
00840241600009 P200037 000

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