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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 K951087
Device Name TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD
Applicant
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Applicant Contact PAUL MASON
Correspondent
Pacesetter, Inc.
15900 Vaklley View Ct.
Sylmar,  CA  91342
Correspondent Contact PAUL MASON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received03/09/1995
Decision Date 06/29/1995
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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