BOSTON SCIENTIFIC ACCOLADE™ SR PACEMAKER

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

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MAH:
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
class:
Class D medical device
manufactured_by:
Cardiac Pacemakers Incorporated
therapeutic_area:
Cardiovascular
therapeutic_indication:
Indicated for treatment of following conditions: Symptomatic paroxysmal/permanent 2nd/3rd-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal/transient sinus node dysfunction with/without AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia/some symptomatic tachyarrhythmias; Neurovascular syndromes/hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence & who may benefit from increased pacing rates concurrent with increases in min ventilation &/or level of physical activity. Dual-chamber & atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are indicated for treatment: Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; VVI intolerance in presence of persistent sinus rhythm; Low cardiac output/CHF secondary to bradycardia
leaflet_short:
Device System Info:[Sterile Medical Device], Ethylene Oxide Sterilization; Models: ACCOLADE™ SR - L300, Torque Wrench - 6628, AICD Magnet - 6860
authorization_number:
DE0017371
authorization_date:
2015-07-28

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