FDA.reportPublic FDA data

PMA P830045S085

Device
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
Applicant
St. Jude Medical, Inc.
PMA number
P830045
Supplement
S085
Product code
KRG
Decision date
2003-03-20
Classification
Cardiovascular
Generic name
Programmer, pacemaker
Approval order statement
APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A. THESE DEVICES ARE INDICATED AS FOLLOWS: IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. 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 BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IS 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 A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY. AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.

Current openFDA PMA Record#

Device
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
Applicant
St. Jude Medical, Inc.
PMA number
P830045
Supplement
S085
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2003-03-20
Decision code
APPR
Date received
2003-03-03
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A. THESE DEVICES ARE INDICATED AS FOLLOWS: IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. 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 BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IS 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 A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY. AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.