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Device | Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu |
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 | S014 |
Date Received | 01/16/2020 |
Decision Date | 12/20/2022 |
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: 1) ZOLL ® OneStep Cable; 2) ZOLL ® X Series Multifunction Therapy Cable; 3) ZOLL ® Propaq MD Multifunction Cable; 4) ZOLL ® X Series OneStep Cable; 5) ZOLL ® Multifunction Therapy Cable with CPR-D Connector; 6) ZOLL ® Pro-padz ® Sterile Electrodes; 7) ZOLL ® Stat-padz ® Electrodes; 8) ZOLL ® Stat-padz ® Deployment Readiness Pack Electrodes; 9) ZOLL ® Pedi-padz ® Electrodes; 10) ZOLL ® Pedi-padz ® II Electrodes; and 11) ZOLL ® Stat-padz ® II Electrodes. |