Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter
FDA premarket approval P210015/S002 · decided 2024-08-15
Approval details
- PMA number
- P210015
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Avive Solutions, Inc.
- Date received
- 2024-02-16
- Decision date
- 2024-08-15
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Brisbane, CA
- Statement
- approval for an alternate contract manufacturing facility for final assembly and packaging
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.