ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes

FDA Premarket Approval P160015 S008

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

New tin-to-wire machines used in the manufacture of electrode assemblies

DeviceZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes
Generic NameAutomated External Defibrillators (non-wearable)
Date Received2020-12-16
Decision Date2020-12-30
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
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
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

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