HeartStart Home Defibrillator and HeartStart Onsite Defibrillator

FDA Premarket Approval P160029 S011

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 audio production test manufacturing specification performed during the final acceptance test

DeviceHeartStart Home Defibrillator and HeartStart Onsite Defibrillator
Generic NameOver-the-counter Automated External Defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
Date Received2021-03-22
Decision Date2021-04-19
PMAP160029
SupplementS011
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell -everett Hwy bothell, WA 98021

Supplemental Filings

Supplement NumberDateSupplement Type
P160029Original Filing
S011 2021-03-22 30-day Notice
S010 2021-02-23 30-day Notice
S009 2021-01-21 30-day Notice
S008
S007 2020-11-16 30-day Notice
S006 2020-07-31 30-day Notice
S005 2020-07-06 30-day Notice
S004 2020-06-19 30-day Notice
S003
S002 2019-11-18 30-day Notice
S001

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