PMA P210015
- Device
- Avive Automated External Defibrillator (AED) System
- Applicant
- Avive Solutions, Inc.
- PMA number
- P210015
- Product code
- MKJ
- Decision date
- 2025-08-13
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- approval for use of the Avive Automated External Defibrillator (AED) System on aircraft.
Current openFDA PMA Record#
- Device
- Avive Automated External Defibrillator (AED) System
- Applicant
- Avive Solutions, Inc.
- PMA number
- P210015
- Supplement
- S007
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-08-13
- Decision code
- APPR
- Date received
- 2025-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for use of the Avive Automated External Defibrillator (AED) System on aircraft.