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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 K951950
Device Name PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
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 Received04/26/1995
Decision Date 08/31/1995
Decision SE - Postmarket Surveillance Required (SESP)
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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