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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, (With Arrhythmia Detection)
510(k) Number K231328
Device Name LUX-Dx II (M302); LUX-Dx II+ (M312)
Applicant
Boston Scientific Corp
4100 Hamline Ave. N.
Alternate Contact,  MN  55112
Applicant Contact Melissa Klamerus
Correspondent
Boston Scientific Corp
4100 Hamline Ave. N.
Alternate Contact,  MN  55112
Correspondent Contact Emily Jallen
Regulation Number870.1025
Classification Product Code
MXD  
Date Received05/08/2023
Decision Date 08/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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