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: HeartStart FRx Defibrillator
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: Philips Medical Systems; 22100 Bothell Everett Hwy; Bothell, WA 98021
• PMA Number: P180028
• Date Received: 08/03/2018
• Decision Date: 05/11/2020
• Product Code: MKJ
• Docket Number: 20M-1368
• Notice Date: 05/12/2020
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the HeartStart FRx Defibrillator (Model 861304). The device is indicated for use on potential victims of sudden cardiac arrest (SCA) with the following symptoms:1) Unconsciousness; and2) Absence of normal breathingThe HeartStart FRx (Model 861304) is indicated for adults over 55 pounds (25 kg). The Model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key (Model 989803139311). If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, proceed using adult treatment without the infant/child key.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014