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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 K922042
Device Name CARDIFIX ENDOCARDIAL PACING LEAD
Applicant
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Applicant Contact KATHLEEN M CHESTER
Correspondent
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Correspondent Contact KATHLEEN M CHESTER
Regulation Number870.3680
Classification Product Code
DTB  
Date Received05/01/1992
Decision Date 04/29/1993
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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