HeartStart FRx Defibrillator (861304)

FDA Premarket Approval P180028 S001

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 for implementation of a semi-automated tool used during speaker assembly

DeviceHeartStart FRx Defibrillator (861304)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhilips Medical Systems
Date Received2020-06-19
Decision Date2020-07-16
PMAP180028
SupplementS001
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
S002 2020-07-06 30-day Notice
S001 2020-06-19 30-day Notice

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