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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 K930876
Device Name SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
Applicant
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
P.O. Box 9221
Sylmar,  CA  91392
Applicant Contact NESTOR KUSNIERZ
Correspondent
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
P.O. Box 9221
Sylmar,  CA  91392
Correspondent Contact NESTOR KUSNIERZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received02/19/1993
Decision Date 06/15/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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