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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceMAXIM PFS MODEL 033-301
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP920011
Date Received03/17/1992
Decision Date11/07/1996
Withdrawal Date10/31/2005
Product Code DTB 
Docket Number 97M-0275
Notice Date 07/08/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MAXIM(TM)(PFS) MODEL 033-301 PACING LEAD. THIS DEVICE IS INTENDED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE WHEN USED WITH A COMNPATIBLE PULSE GENERATOR
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