AED 3 Defibrillator with Uni-Padz

FDA Premarket Approval P160015 S004

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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160015.

DeviceAED 3 Defibrillator with Uni-Padz
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL MEDICAL CORPORATION
Date Received2020-03-27
Decision Date2020-06-05
PMAP160015
SupplementS004
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824

Supplemental Filings

Supplement NumberDateSupplement Type
P160015Original Filing
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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