HeartStart FRx Defibrillator

FDA Premarket Approval P180028 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

Changes to the inspection procedures for components and subassemblies used to build the heartstart family of defibrillators.

DeviceHeartStart FRx Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2020-07-31
Decision Date2020-08-22
PMAP180028
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 22100 Bothell Everett Hwy bothell, WA 98021

Supplemental Filings

Supplement NumberDateSupplement Type
P180028Original Filing
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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