AngelMed Guardian System

FDA Premarket Approval P150009 S005

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

A new component manufacturer for the external patient electronics system

DeviceAngelMed Guardian System
Generic NameAcute Coronary Syndrome Event Detector
Date Received2021-01-19
Decision Date2021-02-17
Product CodeQBI 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724

Supplemental Filings

Supplement NumberDateSupplement Type
P150009Original Filing
S005 2021-01-19 30-day Notice
S004 2020-12-01 30-day Notice
S003 2020-07-28 30-day Notice
S001 2018-05-09 Normal 180 Day Track No User Fee

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