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.

DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic NameWearable Automated External Defibrillator
ApplicantKestra Medical Technologies, Inc.
Date Received2021-09-15
Decision Date2021-11-19
PMAP200037
SupplementS001
Product CodeMVK 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Kestra Medical Technologies, Inc. 3933 Lake Washington Boulevard, N.e. suite 200 kirkland, WA 98033

Supplemental Filings

Supplement NumberDateSupplement Type
P200037Original Filing
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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