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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K920530
Device Name INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
Applicant
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Applicant Contact ALAINE MEDIO
Correspondent
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Correspondent Contact ALAINE MEDIO
Regulation Number870.3610
Classification Product Code
DXY  
Date Received02/05/1992
Decision Date 03/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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