PMA P200037S016
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S016
- Product code
- MVK
- Decision date
- 2025-04-25
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- a new process of reclaiming a component of a previously deployed device
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S016
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-04-25
- Decision code
- OK30
- Date received
- 2025-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new process of reclaiming a component of a previously deployed device