Defibtech Automated External Defibrillator (AED) Systems

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160032 S001

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

Change to the manufacturing test limit acceptance criteria on two test stations (base functional test and system functional test) for the defibtech ddu-100 series and ddu-2000 series aeds.

DeviceDefibtech Automated External Defibrillator (AED) Systems
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantDEFIBTECH, LLC
Date Received2018-11-09
Decision Date2018-12-06
PMAP160032
SupplementS001
Product CodeMKJ
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEFIBTECH, LLC 741 Boston Post Road suite 201 guilford, CT 06437

Supplemental Filings

Supplement NumberDateSupplement Type
P160032Original Filing
S010 2021-06-14 Real-time Process
S009 2020-07-27 Real-time Process
S008 2020-07-21 Real-time Process
S007 2020-05-26 30-day Notice
S006 2020-05-08 30-day Notice
S005
S004 2020-01-27 Real-time Process
S003
S002
S001 2018-11-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00815098020195 P160032 000

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