AngelMed Guardian® System

FDA Premarket Approval P150009 S006

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

An additional supplier of capacitors used in the exd system

DeviceAngelMed Guardian® System
Generic NameAcute Coronary Syndrome Event Detector
ApplicantANGEL MEDICAL SYSTEMS INC.
Date Received2021-08-26
Decision Date2021-09-17
PMAP150009
SupplementS006
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
S006 2021-08-26 30-day Notice
S005 2021-01-19 30-day Notice
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

NIH GUDID Devices

Device IDPMASupp
00850012625155 P150009 000
00850012625018 P150009 000
00850012625025 P150009 000
00850012625032 P150009 000
00850012625049 P150009 000
00850012625056 P150009 000
00850012625063 P150009 000
00850012625070 P150009 000
00850012625087 P150009 000
00850012625094 P150009 000
00850012625100 P150009 000
00850012625124 P150009 000
00850012625131 P150009 000
00850012625148 P150009 000
00850012625001 P150009 000

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