HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

Detalles del retiro

Fabricante

Thoratec Corp.

Distribuidor

Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and South Korea.

Lote

HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-002356 MLP-002361 MLP-002365 MLP-002450 MLP-002455 MLP-002456 MLP-002472 MLP-002475 MLP-002510 MLP-002514 MLP-002518 MLP-002519 MLP-002520 MLP-002530 MLP-002536 MLP-002538 MLP-002539 MLP-002543 MLP-002589 MLP-002597 MLP-002603 MLP-002633 MLP-002643 MLP-002646 MLP-002650 MLP-002654 MLP-002660 MLP-002663 MLP-002666 MLP-002805 MLP-002807 MLP-002808 MLP-002809 MLP-002827 MLP-002828 MLP-002838 MLP-002840 MLP-002842 MLP-002844 MLP-002850 MLP-002858 MLP-002957 MLP-003028 MLP-003033 MLP-003057 MLP-003058 MLP-003068 MLP-003070 MLP-003072 MLP-003074 MLP-003077 MLP-003085 MLP-003086 MLP-003089 MLP-003097 MLP-003110 MLP-003114 MLP-003125 MLP-003130 MLP-003131 MLP-003140 MLP-003148 MLP-003186 MLP-003237 MLP-003255 MLP-003257 MLP-003259 MLP-003277 MLP-003291 MLP-003299 MLP-003300 MLP-003302 MLP-003307 MLP-003308 MLP-003314 MLP-003317 MLP-003340 MLP-003347 MLP-003348 MLP-003351 MLP-003352 MLP-003384 MLP-003385 MLP-003388 MLP-003389 MLP-003390 MLP-003441 MLP-003442 MLP-003461 MLP-003466 MLP-003469 MLP-003471 MLP-003571 MLP-003572 MLP-003574 MLP-003577 MLP-003578 MLP-003582 MLP-003588 MLP-003615 MLP-003616 MLP-003617 MLP-003621 MLP-003629 MLP-003654 MLP-003659 MLP-003661 MLP-003689 MLP-003692 MLP-003738 MLP-003741 MLP-003828 MLP-003829 MLP-003858 MLP-003861 MLP-003862 MLP-003863 MLP-003867 MLP-004093 MLP-004110 MLP-004118 MLP-004119 MLP-004125 MLP-004129 MLP-004131 MLP-004137 MLP-004148 MLP-004151 MLP-004153 MLP-004156 MLP-004157 MLP-004165 MLP-004166 MLP-004171 MLP-004212 MLP-004242 MLP-004247 MLP-004267 MLP-004279 MLP-004281 MLP-004293 MLP-004298 MLP-004310 MLP-004384 MLP-004469 MLP-004486 MLP-004490 MLP-004525 MLP-004584 MLP-004591 MLP-004667 MLP-004675 MLP-004686 MLP-004697 MLP-004802 MLP-004805 MLP-004806 MLP-004866 MLP-004867 MLP-004869 MLP-004870 MLP-004874 MLP-004876 MLP-004877 MLP-004878 MLP-004884 MLP-004885 MLP-004887 MLP-004893 MLP-004954 MLP-004962 MLP-004963 MLP-004968 MLP-004969 MLP-004971 MLP-004983 MLP-004996 MLP-004998 MLP-005006 MLP-005032 MLP-005033 MLP-005036 MLP-005050 MLP-005052 MLP-005054 MLP-005083 MLP-005117 MLP-005122 MLP-005144 MLP-005145 MLP-005183 MLP-005186 MLP-005187 MLP-005193 MLP-005208 MLP-005212 MLP-005215 MLP-005219 MLP-005228 MLP-005258 MLP-005260 MLP-005261 MLP-005291 MLP-005292 MLP-005293 MLP-005298 MLP-005299 MLP-005320 MLP-005322 MLP-005323 MLP-005324 MLP-005328 MLP-005337 MLP-005391 MLP-005393 MLP-005396 MLP-005398 MLP-005402 MLP-005410 MLP-005411 MLP-005414 MLP-005416 MLP-005438 MLP-005440 MLP-005444 MLP-005460 MLP-005468 MLP-005483 MLP-005484 MLP-005485 MLP-005492 MLP-005494 MLP-005497 MLP-005498 MLP-005512 MLP-005531 MLP-005532 MLP-005539 MLP-005540 MLP-005541 MLP-005544 MLP-005552 MLP-005555 MLP-005559 MLP-005576 MLP-005594 MLP-005597 MLP-005600 MLP-005602 MLP-005613 MLP-005620 MLP-005636 MLP-005638 MLP-005641 MLP-005650 MLP-005653 MLP-005655 MLP-005663 MLP-005668 MLP-005680 MLP-005684 MLP-005703 MLP-005704 MLP-005706 MLP-005708 MLP-005729 MLP-005730 MLP-005746 MLP-005747 MLP-005752 MLP-005754 MLP-005769 MLP-005791 MLP

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States