Maxim PFS Model 033-301

FDA premarket approval P920011 · permanent pacemaker Electrode

PMA numberP920011

Approval

Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Received
March 17, 1992
Decision date
November 7, 1996 (APWD)
Supplements
0
Product code
DTB – Permanent Pacemaker Electrode

Official FDA PMA record

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