AngelMed Guardian System

FDA Premarket Approval P150009 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

A material change of the packaging lid for the angelmed guardian system

DeviceAngelMed Guardian System
Generic NameAcute Coronary Syndrome Event Detector
ApplicantANGEL MEDICAL SYSTEMS INC.
Date Received2020-07-28
Decision Date2020-08-28
PMAP150009
SupplementS003
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
S003 2020-07-28 30-day Notice
S002
S001 2018-05-09 Normal 180 Day Track No User Fee

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