ASSURE Wearable Cardioverter Defibrillator (WCD) System

FDA Premarket Approval P200037 S001

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.

Pre-market Approval Supplement Details

Approval for a software update in the off-the-shelf software and resolution of unresolved anomalies.

• Device: ASSURE Wearable Cardioverter Defibrillator (WCD) System
• Generic Name: Wearable Automated External Defibrillator
• Applicant: Kestra Medical Technologies, Inc.
• Date Received: 2021-09-15
• Decision Date: 2021-11-19
• PMA: P200037
• Supplement: S001
• Product Code: MVK
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Kestra Medical Technologies, Inc. 3933 Lake Washington Boulevard, N.e. suite 200 kirkland, WA 98033

Supplemental Filings

Supplement Number	Date	Supplement Type
P200037		Original 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 ID	PMA	Supp
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
00840241600009	P200037	000
00840241600092	P200037	000
00840241600108	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
00840241600115	P200037	000
00840241600238	P200037	000