| 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 | SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y |
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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 | S114 |
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| Date Received | 01/25/2006 |
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| Decision Date | 03/14/2006 |
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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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Approval Order Statement
APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES. THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS. THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION. IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. |
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