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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 K925347
Device Name MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
Applicant
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
P.O. Box 9221
Sylmar,  CA  91392
Applicant Contact LINN EISEN
Correspondent
Siemens-Pacesetter, Inc.
15900 Valley View Ct.
P.O. Box 9221
Sylmar,  CA  91392
Correspondent Contact LINN EISEN
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/22/1992
Decision Date 06/10/1993
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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