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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 K844260
Device Name MODEL 476-03 PACING LEAD
Applicant
Intermedics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact DAVID MAKANANI
Correspondent
Intermedics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact DAVID MAKANANI
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/05/1984
Decision Date 03/28/1985
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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