Cardinal Health Multifunctional Defibrillation Electrode
FDA premarket approval P190007 · decided 2020-08-07
Approval details
- PMA number
- P190007
- Trade name
- Cardinal Health Multifunctional Defibrillation Electrode
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Cardinalhealth
- Date received
- 2019-03-07
- Decision date
- 2020-08-07
- Days to decision
- 519 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mansfield, MA
- Statement
- 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) defibril
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