PMA P200037
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S006
- Product code
- MVK
- Decision date
- 2026-04-14
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- updates to the tester used for final acceptance
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S019
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2026-04-14
- Decision code
- OK30
- Date received
- 2026-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the tester used for final acceptance