| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ZOLL X Series, Propaq MD, and X Series Advanced |
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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 & 271 Mill Rd.
Chelsmford, MA 01824 |
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| PMA Number | P160022 |
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| Supplement Number | S013 |
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| Date Received | 09/03/2019 |
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| Decision Date | 08/25/2020 |
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| Product Code |
MKJ |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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 a software update to Version 02.34 (including implementation of Real Bag-Valve Mask Help Ventilation Feedback (Real BVM Help), a traumatic brain injury dashboard (TBI Dashboard), and the ability to retry to 12-Lead electrocardiograph report transmission up to five times), the addition of the AccuVent Sensor System accessory, and the rebranding of the device from X Series to X Series Advanced. |
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