X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

FDA Premarket Approval P160022 S025

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

An additional test fixture and selective solder machine used during printed circuit board assembly (pcba) manufacturing

DeviceX Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL MEDICAL CORPORATION
Date Received2020-12-21
Decision Date2021-01-05
PMAP160022
SupplementS025
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824-4105

Supplemental Filings

Supplement NumberDateSupplement Type
P160022Original Filing
S025 2020-12-21 30-day Notice
S024 2020-12-17 30-day Notice
S023 2020-11-24 30-day Notice
S022 2020-09-16 30-day Notice
S021 2020-09-14 30-day Notice
S020
S019
S018 2020-05-29 30-day Notice
S017
S016
S015
S014
S013
S012 2019-07-26 30-day Notice
S011 2019-05-13 Real-time Process
S010 2019-04-08 Real-time Process
S009 2019-03-19 30-day Notice
S008
S007 2018-08-10 Real-time Process
S006 2018-06-07 Real-time Process
S005 2018-06-07 Real-time Process
S004 2018-05-18 Real-time Process
S003 2018-04-30 30-day Notice
S002 2018-04-30 30-day Notice
S001 2018-01-16 Real-time Process

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