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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 K854963
Device Name S80 IMPLANTABLE CARDIAC PACING LEAD
Applicant
Sorin Biomedica, Fiat, USA, Inc.
Via Crescentino
13040 Saluggia (Vc)
Italy,  IT
Applicant Contact MARIA VARGA
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
Via Crescentino
13040 Saluggia (Vc)
Italy,  IT
Correspondent Contact MARIA VARGA
Regulation Number870.3680
Classification Product Code
DTB  
Date Received12/11/1985
Decision Date 06/24/1986
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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