Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: Philips HeartStart FR3 Defibrillator
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: PHILIPS MEDICAL SYSTEMS, INC.; 22100 Bothell-Everett Highway; Bothell, WA 98021
• PMA Number: P160028
• Date Received: 07/29/2016
• Decision Date: 05/11/2020
• Product Code: MKJ
• Docket Number: 20M-1367
• Notice Date: 05/08/2020
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Philips HeartStart FR3 Defibrillator. The models 861388 and 861389 are indicated for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and pulseless ventricular tachycardias (VTs). The models 861388 and 861389 are used with the SmartPads III or DP defibrillator pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness;2) Absence of normal breathing; and3) Absence of pulse or signs of circulationThe models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or greater than 8 years old. The models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005