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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name recorder, event, implantable cardiac, (without arrhythmia detection)
510(k) Number K163407
Device Name Confirm Rx Insertable Cardiac Monitor (ICM) System
Applicant
St. Jude Medical, Inc.
15900 Valley View Ct.
sylmar,  CA  91342
Applicant Contact jennifer dunham
Correspondent
St. Jude Medical, Inc.
15900 Valley View Ct.
sylmar,  CA  91342
Correspondent Contact jennifer dunham
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Code
DSI  
Date Received12/05/2016
Decision Date 09/29/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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