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 | TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133 |
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 | S016 |
Date Received | 07/11/2002 |
Decision Date | 12/18/2002 |
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 ADDITION OF THE AUTOSENSING FEATURE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT II, MODELS DR233 AND SR133, AND IS INDICATED FOR RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD DEGREE AV BLOCK; 2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; 3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; 4) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; 5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.THE MODEL DR233 IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHOM 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: 1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
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