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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 K972500
Device Name TIR/TIJ AND POLYROX
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact LAUREN L FOOTE CHRISTENSEN
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact LAUREN L FOOTE CHRISTENSEN
Regulation Number870.3680
Classification Product Code
DTB  
Date Received07/03/1997
Decision Date 03/04/1998
Decision SE SUBJECT TO TRAKING & PMS (PT)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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