AED Plus

FDA Premarket Approval P160015 S014

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

DeviceAED Plus
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL MEDICAL CORPORATION269 & 271 Mill Roadchelmsford, MA 01824 PMA NumberP160015 Supplement NumberS014 Date Received05/20/2022 Decision Date05/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-20
Decision Date2022-05-27
PMAP160015
SupplementS014
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressZOLL MEDICAL CORPORATION
269 & 271 Mill Road
chelmsford, MA 01824 PMA NumberP160015 Supplement NumberS014 Date Received05/20/2022 Decision Date05/27/2022 Product Code 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  
approval Of Equivalent Resistors Used For The AED Plus Printed Circuit Board Assemblies (PCBA)

Supplemental Filings

Supplement NumberDateSupplement Type
P160015Original Filing
S014 2022-05-20 30-day Notice
S013 2022-02-23 30-day Notice
S012 2021-08-06 30-day Notice
S011 2021-02-24 30-day Notice
S010 2021-02-16 30-day Notice
S009 2020-12-18 30-day Notice
S008 2020-12-16 30-day Notice
S007 2020-12-15 30-day Notice
S006 2020-09-28 30-day Notice
S005
S004 2020-03-27 Normal 180 Day Track No User Fee
S003 2020-01-03 30-day Notice
S002 2018-08-23 135 Review Track For 30-day Notice
S001

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