A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1

Detalles del retiro

Fabricante

Medtronic Neuromodulation

Distribuidor

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.

Lote

Versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). 1. Model Number 64001, GTIN (Serial Numbers): 00613994544940 (N733965, N733969, N753252, N775354, N776291, N778120, N782773); 00613994604477 (0212774778, 0212775744, 0212775759, 0212776600, 0212793056, 0212804629, 0212805718, 0212864338, 0212874932, 0212890560, 0212890575, 0212895213, 0212895214, 0212895215, 0212907133, 0212932970, 0212932973, 0212932974, 0212935897, 0213003936, 0213011214, 0213037083, 0213103554, 0213103836, 0213103947, 0213119751, 0213126252, 0213126253, 0213126254, 0213126257, 0213126258, 0213126259, 0213145327, 0213238728, 0213238729, 0213238730, 0213238731, 0213238732, 0213238733, 0213296336, 0213296338, 0213296636, 0213336983, 0213336984, 0213379975, 0213391332, 0213403188, 0213410729, 0213447187, 0213453300, 0213453301, 0213462755, 0213462757, 0213494778, 0213503190, 0213512318, 0213512796, 0213513281, 0213526864, 0213526865, 0213526866, 0213526867, 0213526868, 0213526869, 0213526870, 0213526871, 0213526872, 0213557150, 0213557151, 0213557152, 0213566074, 0213575790, 0213589299, 0213612423, 0213612424, 0213612425, 0213627695, 0213632311, 0213632313, 0213643879, 0213643880, 0213649861, 0213649862, 0213649863, 0213649865, 0213649867, 0213649868, 0213649869, 0213649870, 0213649872, 0213649873, 0213649874, 0213649875, 0213649876, 0213662356, 0213917402, 0213938623, 0213938624, 0213938625, 0213938626, 0213938638, 0214153105, 0214153106, 0214220352, 0214220353, 0214220354, 0214220355, 0214220357, 0214221962, 0214221963, 0214447748, 0214447749, 0214490072, 0214494047, 0214494053, 0214494054, 0214494055, 0214494056, 0214503001, 0214528433, 0214537122, 0214537123, 0214539376, 0214574012, 0214574462, 0214617689, 0214617821, 0214694530, 0214694659, 0214734073, 0214734078, 0214734591, 0214735109, 0214735110, 0214827966, 0214892177, 0214892179, 0214899543, 0215002059, 0215039974, 0215068207, 0215069053, 0215157787, 0215170344, 0215172048, 0215189210, 0215191813, 0215204255, 0215546041, 0215546042, 0215546043, 0215546044, 0215624458, 0215631140, 0215732518, 0215744823, 0215774217, 0215781838, 0215781840, 0215782467, 0215782468, 0215782722, 0215796016, 0215796020, 0215803678, 0215803679, 0215857526, 0215857530, 0215898037, 0215899117, 0215899118, 0216018172, 0216171381, 0216171382, 0216207616, 0216346119, 0216377773, 0216403976, 0216419016, 0216499028, 0216499029, 0216499030, 0216499031, 0216658942, 0216658943, 0216664566, 0216759284, 0216774939, 0216774940, 0216810077, 0216810078, 0216810079, 0216810080, 0216810081, 0216919717, 0216919718, 0216970034, 0216977281, 0217000199, 0217046494, 0217057275, 0217067679, 0217067680, 0217067722, 0217068512, 0217068513, 0217068514, 0217170714, 0217170715, 0217170716, 0217170717, 0217170718, 0217170719, 0217170720, 0217179190, 0217179191, 0217179192, 0217179193, 0217179195, 0217179196, 0217179197, 0217179198, 0217179199, 0217306044, 0217306045, 0217309986, 0217309987, 0217309988, 0217309989, 0217309990, 0217309991, 0217309992, 0217333857, 0217333858, 0217333859, 0217333860, 0217333861, 0217333862, 0217333863, 0217440249, 0217596169, 0217596170, 0217619906, 0217664192, 0217671944, 0217671945, 0217750243, 0217927627, 0218001371, 0218173517, 0218318172, 0218318175, 0218318178); 00613994604484 (0213209850, 0213288462, 0213293456, 0213293457, 0213293458, 0213352261, 0213419249, 0213419340, 0213473603, 0213495294, 0213495295, 0213495296, 0213495297, 0213495298, 0213495299, 0213495340, 0213495341, 0213495342, 0213559327, 0213716708, 0213766926, 0213890732, 0213890733, 0214094542, 0214311406, 0214311407, 0214311408, 0214311414, 0214311415, 0214311416, 0214311419, 0214311474, 0214311475, 0214311476, 0214311477, 0214319850, 0214319853, 0214319967, 0214319968, 0214331598, 0214331599, 0216688332, 0216812514, 0217671913, 0217826925, 0217829246, 0217829247, 0217829248); 00613994604491 (0213925833, 0214282967, 0214282968, 02143016

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States