Powerheart G5 Automated External Defibrillator
FDA premarket approval P160033/S002 · decided 2019-07-25
Approval details
- PMA number
- P160033
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Powerheart G5 Automated External Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2019-04-29
- Decision date
- 2019-07-25
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for updates to the Powerheart AED G5 device.
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