Philips HeartStart FR3 Defibrillator

FDA Premarket Approval P160028

Pre-market Approval Supplement Details

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: • unresponsiveness• absence of normal breathing• 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.

DevicePhilips HeartStart FR3 Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
Date Received2016-07-29
Decision Date2020-05-11
PMAP160028
SupplementS
Product CodeMKJ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell Everett Highway bothell, WA 98021
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P160028Original Filing

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