PMA P200037S006
- Device
- ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S006
- Product code
- MVK
- Decision date
- 2023-01-10
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Utilizing a new washer for the printed circuit board assembly of critical components.
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S006
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2023-01-10
- Decision code
- OK30
- Date received
- 2022-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Utilizing a new washer for the printed circuit board assembly of critical components.