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 | VITATRON DA+ C SERIES PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S014 |
Date Received | 02/20/2003 |
Decision Date | 09/16/2003 |
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 MODIFICATIONS TO RATE RESPONSE FEATURES, ADDITION OF TELEMETRY B, AND OTHER DIAGNOSTIC ENHANCEMENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/VITATRON DA+ C-SERIES IMPLANTABLE GENERATORS AND IS INDICATED AS FOLLOWS: 1) DUAL CHAMBER PACING IS INDICATED IF AV SYNCHRONY NEEDS TO BE RESTORED IN ORDER TO OPTIMIZE CARDIAC OUTPUT. FOR EXAMPLE, PATIENTS WITH SYMPTOMATIC SECOND OR THIRD DEGREE AV BLOCK. 2) DUAL CHAMBER RATE RESPONSIVE PACING MODES ARE OF SPECIFIC BENEFIT TO PATIENTS WITH CHRONOTROPIC INCOMPETENCE OF THE SINUS NODE. 3) RATE RESPONSIVE MODES CAN HELP PATIENTS WHO HAVE A REQUIREMENT FOR ANINCREASE IN PACING RATE IN RESPONSE TO PHYSICAL ACTIVITY. 4) SINGLE CHAMBER VENTRICULAR PACING CAN HELP PATIENTS WITH PERMANENT ATRIALTACHYARRHYTHMIAS, INCLUDING ATRIAL FIBRILLATION AND FLUTTER. 5) SINGLE CHAMBER ATRIAL PACING CAN HELP PATIENTS WITH SYMPTOMATIC BRADYARRHYTHMIASAND NORMAL AV CONDUCTION. |
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