Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S076 |
Date Received | 03/08/2001 |
Decision Date | 07/11/2001 |
Withdrawal Date
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06/20/2007 |
Product Code |
KRG |
Docket Number | 01M-0461 |
Notice Date | 10/11/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTEGRITY AFX DR MODEL 5346 PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: 1)SYNCOPE 2) PRESYNCOPE 3) FATIGUE 4) DISORIENTATION 5) OR ANY COMBINATION OF THOSE 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: 1) SICK SINUS SYNDROME 2) CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK 3) RECURRENT ADAMS-STOKES SYNDROME 4) 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: 1) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST 2) CHRONIC ATRIAL FIBRILLATION 3) SEVERE PHYSICAL DISABILITY. DYNAMIC ATRIAL OVERDRIVE IS INDICATED FOR SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS INCLUDING PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS. |
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