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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K844814
Device Name BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Applicant Contact DAVID M MAKANANI
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Correspondent Contact DAVID M MAKANANI
Regulation Number870.3620
Classification Product Code
DTD  
Date Received12/11/1984
Decision Date 08/29/1985
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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