PMA P830045S079

Device: IDENTITY PULSE GENERATOR MODEL DR 5370
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S079
Product code: KRG
Decision date: 2001-11-27
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL DR 5370. THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS. RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMPTOMATIC BILATERAL BUNDLE BRANCH CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IN INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS. VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.

Current openFDA PMA Record#

Device: IDENTITY PULSE GENERATOR MODEL DR 5370
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S079
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2001-11-27
Decision code: APPR
Date received: 2001-10-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL DR 5370. THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS. RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMPTOMATIC BILATERAL BUNDLE BRANCH CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IN INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS. VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.