PMA P920032

Device: MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S008
Product code: DTE
Decision date: 2002-02-20
Generic name: Pulse-generator, pacemaker, external
Approval order statement: APPROVAL FOR THE MICRO-PACE MODEL 4580. THE DEVICE IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE. SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION. ADDITIONALLY, TEMPORARY CARDIAC PACING HAS BEEN USED TO OVERDRIVE AND THEREBY TERMINATE ATRIAL ARRHYTHMIAS, INCLUDING ATRIAL FLUTTER. IT HAS BEEN USED IN PREPARATION FOR PERMANENT PACEMAKER IMPLANTATION TO ASCERTAIN THE THRESHOLDS FOR SENSING AND PACING ON THE ACUTE LEAD SYSTEM."

Current openFDA PMA Record#

Device: MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER
Applicant: Pace Medical
PMA number: P920032
Supplement: S008
Product code: DTE
Generic name: Pulse-generator, pacemaker, external
Decision date: 2002-02-20
Decision code: APPR
Date received: 2001-08-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MICRO-PACE MODEL 4580. THE DEVICE IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE. SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION. ADDITIONALLY, TEMPORARY CARDIAC PACING HAS BEEN USED TO OVERDRIVE AND THEREBY TERMINATE ATRIAL ARRHYTHMIAS, INCLUDING ATRIAL FLUTTER. IT HAS BEEN USED IN PREPARATION FOR PERMANENT PACEMAKER IMPLANTATION TO ASCERTAIN THE THRESHOLDS FOR SENSING AND PACING ON THE ACUTE LEAD SYSTEM."