Advanced Bionics Corporation

Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943

Neurological Devices

3

Yes

Worldwide.

Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.

Serial Numbers:  351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303.

Ear, Nose, and Throat Devices

3

Yes

Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.

HiRes 90K devices with Helix Electrodes Model CI 1400-02H || The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.

Serial Numbers:  352454 352743 352779 352908 353919 355514 355618 355700 355876 355889 356171 356180 356206 356361 356477 356561 356723 356746 356891 356900 356910 357104 357153 357171 357249 357265 357341 357417 357426 357452 357464 357490 357525 357548 357621 357645 357681 357687 357692 357696 357711 357772 357784 450211 450257 450346 450350 450363 450457 450487 450489 450495 450498 450511 450517 450521 450523 450525 450527 450530 450534 450535 450541 450545 450550 450552 450555 450559 450566 450567 450573 450581 450590 450624 450628 450661 450706 450721 450724 450727 450735 450817

Ear, Nose, and Throat Devices

3

Yes

Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.

Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H || The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.

Serial Numbers: 316001 315123 315913 316001 316070 318275 319856 320644 320806 321180 321554 321720 322009 322438 322483 322841 323064 323133 323239 323371 323401 323461 323529 323979 324168 324186 324671 324735 324781 324845 324981 325065 325205 325407 325468 325637 325760 325947 326005 326178 326187 326553 326680 326747 326805 326811 326815 326849 326853 326863 326895 327093 327195 327235 327414 327566 327590 327693 327700 327707 327741 327764 327979 327996 328000 328061 328086 328198 328239 328398 328519 328608 329064 329165 329231 329244 329294 329299 329387 329397 329414 329436 329441 329445 329487 329509 329590 329626 329649 329670 329713 329734 329793 329794 329823 329850 329857 329858 329879 329913 329948 329968 329988 330577 330773 330803 402329 402342 402535 402588 402597 402610 402613 402622 402630 402634 402638 402656 402663 402664 402684 402687 402694 402697 402717 402771 402772 402786 402800 402830 402831 402921 402934 402938 402939 402940 402941 402942 402943 402947 402948 402953 402976 402979 402982 402985 402987 402991 402994 403010 403020 403023 403025 403030 403037 403057 403069 403088 403098 403099 403100 403115 403122 403125 403135 403139 403142 403144 403150 403169 403172 403186 403199 403200 403231 403238 403264 403283 403335 403349 403380 403386 403397 403402 403420 403437 403445 403470 403488 403490 403495 403497 403498 403501 403502 403505 403512 403514 403516 403520 403527 403531 403540 403542 403552 403557 403562 403563 403566 403570 403572 403574 403597 403601 403607 403608 403609 403611 403617 403622 403623 403625 403644 403659 403667 403669 403695 403697 403711 403718 403758 403766 403790 403792 403798 403800 403812 403820 403823 403829 403834 403836 403849 403850 403852 403861 403862 403866 403870 403872 403874 403879 403885 403886 403888 403902 403907 403910 403911 403913 403915 403916 403917 403923 403924 403938 403941 403946 403949 403952 403976 403985 403989 403992 403997 404011 404018 404020 404055 404080 404081 404090 404104 404108 404111 404113 404118 404121 404125 404129 404131 404133 404139 404141 404143 404146 404149 404151 404156 404157 404168 404173 404181 404184 404191 404193 404199 404206 404212 404225 404227 404254 404255 404258 404270 404279 404319 404326 404372 404381 404402 404414 404415 404444 404456 404459 404483 404495 404500 404519 404521 404537 404550

Ear, Nose, and Throat Devices

3

Yes

Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.

Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 || Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.

Model Number: SC-9305, Lot Number 170338

Neurological Devices

3

Yes

Worldwide Distribution including Great Britian

OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 || The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.