HeartStart FRx Defibrillator (861304)

FDA Premarket Approval P180028 S010

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

A change to the hardliner sealing process for the smart padz ii

DeviceHeartStart FRx Defibrillator (861304)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2021-08-30
Decision Date2021-09-24
PMAP180028
SupplementS010
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
S010 2021-08-30 30-day Notice
S009 2021-05-21 30-day Notice
S008 2021-05-17 Special (immediate Track)
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

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