Approval for the cardinal health multifunctional defibrillation electrodes. These devices are indicated for: the multifunctional defibrillation electrodes are intended to transfer energy from a cardiac defibrillator or pacer to the body of a patient for the purpose of defibrillation, synchronized cardioversion, pacing, or for ecg monitoring. The kendall™ and medi-trace™ cadence adult multi-function defibrillation electrodes with connectors intended for use with physio-control lifepak (lp) defibrillators are compatible with physio-control / stryker lp 15, lp 20, lp 20e, lp 1000, lp cr plus, and lp express defibrillators with the exception of the kendall™ 1010p adult multi-function defibrillation electrode, which is compatible with physio-control lp 20 and lp 20e defibrillators and the physio-control fast-patch® cable. The medi-trace™ cadence pediatric multi-function defibrillation electrodes with connectors intended for use with physio-control / stryker defibrillators are compatible with physio-control lp 15, lp 20, and lp 20e defibrillators. The kendall™ and medi-trace™ cadence adult multi-function defibrillation electrodes with connectors intended for use with zoll defibrillators are compatible with zoll r series bls, r series plus, r series als, x series, and propaq md defibrillators. The physio-control/stryker quik-combo adult pacing/defibrillation/ecg electrodes and quik-combo pediatric pacing/defibrillation/ecg electrodes are compatible with lp 15, lp 20, and lp 20e defibrillators. The physio-control/stryker quik-combo pacing/defibrillation/ecg electrode with redi-pak preconnect system is compatible with lp 15, lp 20, lp 20e, lp 1000, lp cr plus, and lp express defibrillators.
| Device | Cardinal Health Multifunctional Defibrillation Electrode |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Cardinal Health |
| Date Received | 2019-03-07 |
| Decision Date | 2020-08-07 |
| PMA | P190007 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cardinal Health 15 Hampshire Street mansfield, MA 02048 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190007 | Original Filing |