PMA P920032S002

Device: MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S002
Product code: JOQ
Decision date: 1996-04-26
Generic name: Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Approval order statement: APPROVAL FOR THE PACESETTER, INC., MODEL 3070B PRIVATE LABEL VERSION OF THE PACE MEDICAL MODEL 4575

Current openFDA PMA Record#

Device: MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S002
Product code: JOQ
Generic name: Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Decision date: 1996-04-26
Decision code: APPR
Date received: 1995-11-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE PACESETTER, INC., MODEL 3070B PRIVATE LABEL VERSION OF THE PACE MEDICAL MODEL 4575