PMA P920032S006

Device: MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S006
Product code: DTE
Decision date: 2001-04-06
Generic name: Pulse-generator, pacemaker, external
Approval order statement: APPROVAL TO MODIFY THE TEMPORARY PACEMAKERS BY REPLACING THE ZENER DIODES USED FOR PROTECTING THE INTERNAL ELECTRONICS FROM HIGH VOLTAGE TRANSIENTS WITH A TRANSIENT VOLTAGE SUPPRESSOR.

Current openFDA PMA Record#

Device: MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S006
Product code: DTE
Generic name: Pulse-generator, pacemaker, external
Decision date: 2001-04-06
Decision code: APPR
Date received: 2001-01-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE TEMPORARY PACEMAKERS BY REPLACING THE ZENER DIODES USED FOR PROTECTING THE INTERNAL ELECTRONICS FROM HIGH VOLTAGE TRANSIENTS WITH A TRANSIENT VOLTAGE SUPPRESSOR.