Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
FDA premarket approval P160033 · decided 2018-12-07
Approval details
- PMA number
- P160033
- Trade name
- Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2016-08-03
- Decision date
- 2018-12-07
- Days to decision
- 856 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Approval for the Powerheart® AED G3, Powerheart® AED G3 Plus, and the Powerheart® AED G5.The Powerheart® AED G3 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 Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's
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