Avive Automated External Defibrillator (AED) System
FDA premarket approval P210015/S005 · decided 2025-01-29
Approval details
- PMA number
- P210015
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avive Automated External Defibrillator (AED) System
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Avive Solutions, Inc.
- Date received
- 2024-12-26
- Decision date
- 2025-01-29
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Brisbane, CA
- Statement
- to add an alternate supplier for PCBAs used in the manufacture of the Avive AED
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