PMA P200037S003
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S003
- Product code
- MVK
- Decision date
- 2021-12-17
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Change to a supplier of the silver-plating process of the ECG electrode.
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S003
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2021-12-17
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a supplier of the silver-plating process of the ECG electrode.