AED Plus

FDA Premarket Approval P160015 S003

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

Approval for an additional rework process on the replacement of the surface mount capacitors utilized on the aed plus device printed circuit board assembly (pcba)

DeviceAED Plus
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL MEDICAL CORPORATION
Date Received2020-01-03
Decision Date2020-01-24
PMAP160015
SupplementS003
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
S003 2020-01-03 30-day Notice
S002 2018-08-23 135 Review Track For 30-day Notice
S001

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