PMA P200037S004

Device: Assure Wearable Cardioverter Defibrillator (WCD) system
Applicant: Kestra Medical Technologies, Inc.
PMA number: P200037
Supplement: S004
Product code: MVK
Decision date: 2022-10-25
Generic name: Wearable automated external defibrillator
Approval order statement: Approval for a revision to the software system to version 5.0 with a feature to provide additional information to the physician about the patients health.

Current openFDA PMA Record#

Device: Assure Wearable Cardioverter Defibrillator (WCD) system
Applicant: Kestra Medical Technologies, Inc.
PMA number: P200037
Supplement: S004
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2022-10-25
Decision code: APPR
Date received: 2022-06-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a revision to the software system to version 5.0 with a feature to provide additional information to the physician about the patients health.