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Device | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER |
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 | S001 |
Date Received | 08/04/1998 |
Decision Date | 12/22/1998 |
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 functional changes to reduce size and update algorithms and features in previously approved Chorus RM Model 7034 and Opus RM Model 4534. The device, as modified, will be marketed under the trade name Brio and is indicated for: The generally accepted patient conditions warranting chronic cardiac pacing which 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 conductions disorders; 4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomaitc tachyarrhythmias; and 5) Vaso-vagal syndrome or hypersensitive carotid sinus syndromes. The Brio is also indicated for dual-chamber and atrial tracking modes in 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: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. |