5d0235d8-c953-43ba-83d6-8096f77ea80aUpdatePublished32021-04-062018-07-11In Commercial Distribution08714729975083PrimaryGS1ROTAPRO™H7493930901D0021717889BOSTON SCIENTIFIC CORPORATION1Rotational Atherectomy SystemfalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseP900056166P90005617661205Mechanical atherectomy system, coronary, line-poweredAn assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).falseActiveMCXCATHETER, CORONARY, ATHERECTOMYfalsefalse