| 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 | AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS |
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| Generic Name | Pulse generator, permanent, implantable |
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| Applicant | Abbott Medical
15900 Valley View Court
Sylmar, CA 91335 |
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| PMA Number | P880086 |
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| Supplement Number | S174 |
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| Date Received | 01/22/2009 |
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| Decision Date | 07/15/2009 |
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| Product Code |
NVZ |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS. THE DEVICE IS INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONEAN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS IIIOR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRSDURATION. IMPLANTATION OF ACCENT, ACCENT RF, ANTHEM AND ANTHEM RF DEVICES IS INDICATED IN ONE OR MORE OF THE FOLLOWING PERMANENT CONDITIONS:A) SYNCOPEB) PRESYNCOPEC) FATIGUED) DISORIENTATION DUE TO ARRHYTHMIA/ BRADYCARDIAE) OR 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 (ACCENT MODEL PM2110, ACCENT RF MODEL PM2210, ANTHEM AND ANTHEM RF DEVICES ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING:A) SICK SINUS SYNDROMEB) CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCKC) RECURRENT ADAMS-STOKES SYNDROMED) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSESHAVE BEEN RULED OUT.ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV ANDINTRAVENTRICULAR CONDUCTION SYSTEMS.VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:A) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARRESTB) CHRONIC ATRIAL FIBRILLATIONC) SEVERE PHYSICAL DISABILITY....(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL INFORMATION) |
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