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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 K963738
Device Name STELA MODEL BJ44 AND BJ45 PACING LEADS
Applicant
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact CATHERINE G GOBLE
Correspondent
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact CATHERINE G GOBLE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/17/1996
Decision Date 05/23/1997
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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