PMA P200037S014
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S014
- Product code
- MVK
- Decision date
- 2024-10-08
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- a new supplier for material used in the base garment
Current openFDA PMA Record#
- Device
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Applicant
- Kestra Medical Technologies, Inc.
- PMA number
- P200037
- Supplement
- S014
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2024-10-08
- Decision code
- OK30
- Date received
- 2024-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new supplier for material used in the base garment