HeartStart FR3 Defibrillator

FDA Premarket Approval P160028 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Updates to the inspection process for various device components and sub-assemblies

DeviceHeartStart FR3 Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
Date Received2020-11-16
Decision Date2020-12-16
PMAP160028
SupplementS003
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell Everett Highway bothell, WA 98021

Supplemental Filings

Supplement NumberDateSupplement Type
P160028Original Filing
S003 2020-11-16 30-day Notice
S002
S001 2020-07-06 30-day Notice

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