BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

FDA premarket approval P920032/S007 · decided 2001-10-26

Approval details

PMA number: P920032
Supplement: S007
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170
Generic name: Pulse-generator, pacemaker, external
Applicant: Pace Medical
Date received: 2001-04-24
Decision date: 2001-10-26
Days to decision: 185 days
Decision code: APPR
Product code: DTE
Advisory committee: Cardiovascular
Expedited review: No
Location: Waltham, MA
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 BLOC

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Record	Firm	Date
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (K011980)	Pace Medical	2001-09-12
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (K012392)	Pace Medical	2001-09-04
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204)	Pace Medical	2000-10-18
MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497)	Pace Medical	2000-10-10
MODEL 4815 ADAPTER (K002496)	Pace Medical	2000-10-10
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 (K001180)	Pace Medical	2000-06-27
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (K925143)	Pace Medical	1994-09-27
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES (K931662)	Pace Medical	1993-08-31