Avive Automated External Defibrillator (AED) System
FDA premarket approval P210015/S007 · decided 2025-08-13
Approval details
- PMA number
- P210015
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Avive Automated External Defibrillator (AED) System
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Avive Solutions, Inc.
- Date received
- 2025-04-24
- Decision date
- 2025-08-13
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Brisbane, CA
- Statement
- approval for use of the Avive Automated External Defibrillator (AED) System on aircraft.
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