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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 K922972
Device Name MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
Applicant
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Applicant Contact ANTHONY FONSECA
Correspondent
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Correspondent Contact ANTHONY FONSECA
Regulation Number870.3680
Classification Product Code
DTB  
Date Received06/19/1992
Decision Date 01/22/1993
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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