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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K962174
Device Name BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
Applicant
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Applicant Contact LORI KLEINSCHRODT HOLDER
Correspondent
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Correspondent Contact LORI KLEINSCHRODT HOLDER
Regulation Number870.3680
Classification Product Code
DTB  
Date Received06/05/1996
Decision Date 08/21/1996
Decision SE SUBJECT TO TRACKING REG (ST)
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
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