AngelMed Guardian System

FDA Premarket Approval P150009 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

Component change the implantable and external device components of the angelmed guardian system

DeviceAngelMed Guardian System
Generic NameAcute Coronary Syndrome Event Detector
ApplicantANGEL MEDICAL SYSTEMS INC.
Date Received2020-12-01
Decision Date2020-12-22
PMAP150009
SupplementS004
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
S004 2020-12-01 30-day Notice
S003 2020-07-28 30-day Notice
S002
S001 2018-05-09 Normal 180 Day Track No User Fee

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