PMA P200037S018
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S018
- Product code
- MVK
- Decision date
- 2026-03-06
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- approval of software version 5.1.
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S018
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2026-03-06
- Decision code
- APPR
- Date received
- 2025-09-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval of software version 5.1.