HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507

FDA Premarket Approval P160029 S017

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 (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507
Generic NameOver-the-counter Automated External Defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-07-05
Decision Date2022-07-27
PMAP160029
SupplementS017
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 NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
request Approval To Replace The Current Water Spray System On The Hydrogel Heat Cure Line With A New Water Spray System In Order To Reduce The Variation In The Final Gel Water Content

Supplemental Filings

Supplement NumberDateSupplement Type
P160029Original Filing
S017 2022-07-05 30-day Notice
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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