Powerheart G5 AED
FDA premarket approval P160033/S001 · decided 2018-12-20
Approval details
- PMA number
- P160033
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Powerheart G5 AED
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2018-12-17
- Decision date
- 2018-12-20
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for a cybersecurity software update to prevent corruption or modification of the Powerheart G5 AED software executables.
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