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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K851365
Device Name SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
Applicant
Sorin Biomedica, Fiat, USA, Inc.
Jeanne-Marie Varga
375 Park Ave.
New York,  NY  10152
Applicant Contact JEANNE-MARIE VARGA
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
Jeanne-Marie Varga
375 Park Ave.
New York,  NY  10152
Correspondent Contact JEANNE-MARIE VARGA
Regulation Number870.3610
Classification Product Code
DXY  
Date Received04/05/1985
Decision Date 12/03/1985
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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