Devices · Edwards Lifesciences LLC

Acumen Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences LLC is listed for Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044). The FDA list gives March 16, 2018 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QAQ as “Adjunctive Predictive Cardiovascular Indicator”: The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160044

Official FDA database record

Date of final decision

March 16, 2018

Company on the FDA list

Edwards Lifesciences LLC

Lead panel

Cardiovascular

Primary product code

QAQ

openFDA device name for the code

Adjunctive Predictive Cardiovascular Indicator

Device class

2

Regulation number

870.2210

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned