Cleared Traditional

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

K122090 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular

Nov 2012

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K122090 is an FDA 510(k) clearance for the SJM CONFIRM IMPLANTABLE CARDIAC MONITOR, a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II — Special Controls, product code MXC), submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on November 15, 2012, 122 days after receiving the submission on July 16, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K122090 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2012
Decision Date	November 15, 2012
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2800