HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator

FDA Premarket Approval P160029 S016

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

DeviceHeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator
Generic NameOver-the-counter Automated External Defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS016 Date Received05/11/2022 Decision Date06/08/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-11
Decision Date2022-06-08
PMAP160029
SupplementS016
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressPHILIPS MEDICAL SYSTEMS, INC.
22100 Bothell -everett Hwy
bothell, WA 98021 PMA NumberP160029 Supplement NumberS016 Date Received05/11/2022 Decision Date06/08/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
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Supplemental Filings

Supplement NumberDateSupplement Type
P160029Original Filing
S016 2022-05-11 30-day Notice
S015 2022-02-22 30-day Notice
S014
S013 2021-07-30 30-day Notice
S012 2021-05-21 30-day Notice
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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