ANGELMED GUARDIAN SYSTEM

Acute Coronary Syndrome Event Detector

FDA Premarket Approval P150009

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval of the angelmed guardian system. This device is indicated for use in patients who have had prior acute coronary syndrome (acs) events and who remain at high risk for recurrent acs events. The guardian system is indicated as an adjunct to patient recognized symptoms. The guardian system detects potential ongoing acs events, characterized by sustained st segment changes, and alerts the patient to seek medical attention for those potential acs events. A guardian system alert is a more accurate predictor of acs events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without acs events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the guardian system may identify asymptomatic acs events and prompt the patient to seek medical attention.

DeviceANGELMED GUARDIAN SYSTEM
Classification NameAcute Coronary Syndrome Event Detector
Generic NameAcute Coronary Syndrome Event Detector
ApplicantANGEL MEDICAL SYSTEMS INC.
Date Received2015-02-23
Decision Date2018-04-09
Notice Date2018-04-11
PMAP150009
SupplementS
Product CodeQBI
Docket Number18M-1447
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150009Original Filing
S008 2022-08-19 Normal 180 Day Track No User Fee
S007 2022-04-27 Normal 180 Day Track No User Fee
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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