HeartStart FRx Defibrillator

FDA Premarket Approval P180028 S004

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 FRx Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2020-11-16
Decision Date2020-12-16
PMAP180028
SupplementS004
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 22100 Bothell Everett Hwy bothell, WA 98021

Supplemental Filings

Supplement NumberDateSupplement Type
P180028Original Filing
S004 2020-11-16 30-day Notice
S003 2020-07-31 30-day Notice
S002 2020-07-06 30-day Notice
S001 2020-06-19 30-day Notice

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