Powerheart® AED G3 Pro
FDA premarket approval P160034 · decided 2018-12-06
Approval details
- PMA number
- P160034
- Trade name
- Powerheart® AED G3 Pro
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2016-08-04
- Decision date
- 2018-12-06
- Days to decision
- 854 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for the Powerheart® AED G3 Pro.The Powerheart® AED G3 Pro is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 Pro is intende
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