HeartStart FRx Defibrillator

FDA Premarket Approval P180028

Pre-market Approval Supplement Details

The heartstart frx defibrillator (model 861304) is indicated for use on potential victims of sudden cardiac arrest (sca) with the following symptoms:• unconsciousness, and• 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.

DeviceHeartStart FRx Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2018-08-03
Decision Date2020-05-11
PMAP180028
SupplementS
Product CodeMKJ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Philips Medical Systems 22100 Bothell Everett Hwy bothell, WA 98021
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P180028Original Filing

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