MAXIM PFS MODEL 033-301

FDA Premarket Approval P920011

Pre-market Approval Supplement Details

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

DeviceMAXIM PFS MODEL 033-301
Generic NamePermanent Pacemaker Electrode
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
Date Received1992-03-17
Decision Date1996-11-07
Notice Date1997-07-08
PMAP920011
SupplementS
Product CodeDTB 
Docket Number97M-0275
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. sylmar, CA 91342

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Supplement NumberDateSupplement Type
P920011Original Filing

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