Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor ii, prothrombin, factor ix, human, factor x, factor vii - powder and solvent for solution for injection - factor ii (prothrombin) 24-45 iu/mg factor ix, human 30 iu/mg factor x, human 30 iu/mg factor vii, human 25 iu/mg - antihemorrhagics

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; human protein c - powder and solvent for solution for injection - coagulation factor ix, ii, vii and x in combination

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 44862 - cable/lead, external temporary pacemaker, reusable - the cables provide a connection between an external temporary pacemaker and implanted cardiac pacing leads / heart wires for the purpose of transmitting electrical impulses to the heart. the pacing leads / heart wires may also relay information about the hearts activity back to the temporary pacemaker via the cables. the proximal end consists of a connector that plug into the temporary pacemaker or an adaptor and the distal end, which connects to the pacing leads/heart wires.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 44863 - cable/lead, external temporary pacemaker, single-use - the cables provide a connection between an external temporary pacemaker and implanted cardiac pacing leads / heart wires for the purpose of transmitting electrical impulses to the heart. the pacing leads / heart wires may also relay information about the hearts activity back to the temporary pacemaker via the cables. the cables are for single use

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47487 - medical device electrical cable, general purpose - the cables are designed to enable an electrical connection between a pair of medical devices. they include a connector at either end, typically with different connection configurations.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35822 - pacemaker, cardiac, external, noninvasive - reocor are battery-powered external cardiac pacemakers, which can be used in conjunction with temporary pacemaker leads (including myocardial heartwires, endocardial leads and transvenous implantable catheters) for temporary cardiac pacing in clinical settings. the connection to the leads is made directly or via separate patient cables or adaptors, if neccessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 46221 - pacing lead cap - bk sealing caps are intended for use as components of systems designed to treat cardiac fibrillations or arrhythmias. such systems may include pacemaker/pulse generator units, implantable cardioverter/defibrillators (icds), pacemaker or icd leads, and various lead adapters. bk sealing caps provide a permanent insulative barrier of medical-grade silicone between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological environment.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 38141 - cardiac output unit, software - the software is for use with the biotronik renamic. the testing parameters include threshold; sensing (p/r measurement); retrograde conduction; intracardiac electrogram (iegm); ecg; and non-invasive programmed stimulation (nips). the programmer software is used during implantation and follow-up procedures on biotronik pacemakers, cardiac monitors and icds to carry out intraoperative tests; interrogate and program biotronik implantable cardiac monitors, pacemakers and icds.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 45252 - active-implantable-device communicator - renamic programs & tests pacemakers & icds during implantation procedure and follow-ups; displays & prints surface ecgs and intracardiac derivations (iegms), stores parameters; and records ecg/ iegm, and prints follow-up reports. components are: the renamic programmer, renamic pgh, renamic pen, printer paper, electrode clip, ecg patient cable & power cable. information such as heart rate, surface ecg and navigational elements used to select different situation-dependent functions are available renamic is a system that includes the renamic programmer which provides communication with implantable pulse generators or icds during implantation procedure and follow-ups. it is intended to: interrogate, display, printout data of the implants, transfer parameters to the implant, conduct sensing, pacing threshold and impedance tests.