AED Plus

FDA Premarket Approval P160015 S010

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

To eliminate redundant shock testing during manufacture of the aed plus

DeviceAED Plus
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL MEDICAL CORPORATION
Date Received2021-02-16
Decision Date2021-03-09
PMAP160015
SupplementS010
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

Supplemental Filings

Supplement NumberDateSupplement Type
P160015Original Filing
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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