PMA P920032S007

Device: BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170
Applicant: Pace Medical
PMA number: P920032
Supplement: S007
Product code: DTE
Decision date: 2001-10-26
Generic name: Pulse-generator, pacemaker, external
Approval order statement: APPROVAL FOR THE MODEL 4170 BEDSIDE SINGLE CHAMBER, EXTERNAL PULSE GENERATOR. THE MODEL 4170 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."

Current openFDA PMA Record#

Device: BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170
Applicant: Pace Medical
PMA number: P920032
Supplement: S007
Product code: DTE
Generic name: Pulse-generator, pacemaker, external
Decision date: 2001-10-26
Decision code: APPR
Date received: 2001-04-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODEL 4170 BEDSIDE SINGLE CHAMBER, EXTERNAL PULSE GENERATOR. THE MODEL 4170 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."