HeartStart FRx Defibrillator

FDA Premarket Approval P180028 S006

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

Inspection procedure changes for components and sub-assemblies used in the manufacture of the heartstart onsite defibrillator (model m5066a), heartstart home defibrillator (model m5068a) and heartstart frx defibrillator (model 861304)

DeviceHeartStart FRx Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2021-01-21
Decision Date2021-02-12
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
S006 2021-01-21 30-day Notice
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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