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 R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD CHELMSFORD, MA 01824-4105 |
PMA Number | P160022 |
Supplement Number | S016 |
Date Received | 01/31/2020 |
Decision Date | 12/19/2022 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following ZOLL automated external defibrillator (AED) accessories: ZOLL® Pedi-padz® Liquid Gel Electrodes, ZOLL® Adult Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Electrodes, ZOLL® Pedi-padz® Radiolucent Electrodes, ZOLL® CPR-D-padz® Electrodes, ZOLL® CPR Stat-padz® Electrodes, ZOLL® CPR Dura-padz® Reusable Electrodes. |
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