| 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 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) |
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| Generic Name | Automated external defibrillators (non-wearable) |
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| Regulation Number | 870.5310 |
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| Applicant | AED Battery Exchange, LLC
1000 Brown Street, Suite #206
Wauconda, IL 60084 |
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| PMA Number | P190013 |
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| Date Received | 04/29/2019 |
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| Decision Date | 02/02/2021 |
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| Product Code |
MKJ |
| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE). The AED battery supplies power to an AED as required during self maintenance, automated diagnoses, and defibrillation. The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E. The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C. The 5070-ABE is indicated for use with the Philips HeartStart OnSite/Home, models M5066A, M5067A, M5068A, and the FRx, model 861304. The FR3-ABE is indicated for use with the Philips HeartStart FR3, models 861388 and 861389. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 |
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