HeartStart Home Defibrillator and HeartStart OnSite Defibrillator

FDA Premarket Approval P160029 S009

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

Inspection procedure changes for components and sub-assemblies used in the manufacture of the heartstart onsite defibrillator (model m5066a), heartstart home defibrillator (model m5068a) and heartstart frx defibrillator (model 861304)

DeviceHeartStart Home Defibrillator and HeartStart OnSite Defibrillator
Generic NameOver-the-counter Automated External Defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
Date Received2021-01-21
Decision Date2021-02-12
PMAP160029
SupplementS009
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
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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