PMA P200037S021
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S021
- Product code
- MVK
- Decision date
- 2026-09-28
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- an updated workflow for the post-wear data transfer process
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S021
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2026-09-28
- Decision code
- OK30
- Date received
- 2026-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an updated workflow for the post-wear data transfer process