PMA P200037S001
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S001
- Product code
- MVK
- Decision date
- 2021-11-19
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for a software update in the off-the-shelf software and resolution of unresolved anomalies.
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S001
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2021-11-19
- Decision code
- APPR
- Date received
- 2021-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update in the off-the-shelf software and resolution of unresolved anomalies.