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 | SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S022 |
Date Received | 11/16/2004 |
Decision Date | 04/27/2005 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE AAISAFER2 PACING MODE AND THE ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYMPHONY DR 2550 AND IS INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK, SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK, SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS, BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS AND VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT AND VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
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