HeartStart FRx Defibrillator

FDA Premarket Approval P180028 S007

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

Approval of inspection changes for components and subassemblies used to build aeds

DeviceHeartStart FRx Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2021-02-23
Decision Date2021-03-10
PMAP180028
SupplementS007
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
S007 2021-02-23 30-day Notice
S006 2021-01-21 30-day Notice
S005
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.