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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 K851861
Device Name PROGRAMALITH III MODEL 249 PULSE GENERATOR
Applicant
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Applicant Contact NESTOR KUSNIERZ
Correspondent
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Correspondent Contact NESTOR KUSNIERZ
Regulation Number870.3610
Classification Product Code
DXY  
Date Received04/26/1985
Decision Date 05/16/1985
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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