| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Powerheart® AED G3 Pro |
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| Generic Name | Automated external defibrillators (non-wearable) |
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| Regulation Number | 870.5310 |
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| Applicant | Zoll Medical Corporation
269 Mill Road
Chelmsford, MA 01824 |
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| PMA Number | P160034 |
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| Date Received | 08/04/2016 |
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| Decision Date | 12/06/2018 |
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| Product Code |
MKJ |
| Docket Number | 18M-4672 |
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| Notice Date | 12/11/2019 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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 intended to be used by personnel who have been trained in its operation. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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