Premarket Approval (PMA)

• Device: TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: Tz Medical, Inc.; 17750 SW Upper Boones Ferry Rd. #150; Portland, OR 97224
• PMA Number: P200005
• Date Received: 02/03/2020
• Decision Date: 01/09/2024
• Product Code: MKJ
• Docket Number: 24M-0760
• Notice Date: 02/09/2024
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for the TZ Medical Adult Multi-Function Defibrillation Electrodes and Adaptors and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adaptors

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling