Innovative home dialysis solution generation system designed to enhance. Curtin fax, contact person baxter healthcare corporation renal division 1620 waukegan road mcgaw park, il 60085 847 4736079 847 4736952 fax date prepared trade name of device baxter meridian hemodialysis machine common name hemodialysis machine. Baxter wins fda nod for amia dialysis device massdevice. Continuous renal replacement therapy crrt for patients weighing 20. Baxter presents data focused on elevating the quality of care for. Unique software development launches 3d printing initiative to beat.
Baxter to hire 2,000 employees as demand for medical products surge. Guidance for the content of premarket submissions for software contained in medical devices guidance for industry and fda staff may 2005. Pioneering therapy options for people with kidney disease, including peritoneal dialysis and hemodialysis. Compact, portable monitor that accurately measures patients resting energy expenditure to help optimize nutrition therapy technology replaces potentially inaccurate predictive equations expected to launch in the united states at aspen conference in march 2020 baxter international inc. Com este espirito inovador, estamos aliando nossos servicos a tecnologia da internet e acreditamos na melhoria continua da qualidade com mais este servico. Compact, portable monitor that accurately measures patients resting energy expenditure to. As baxter makes preparations to upgrade its colleague pumps in the us it will submit manufacturing and service documentation to the fda in advance of deploying the modifications. Baxter, cosmed win fda clearance for portable metabolism.
Baxter news in peritoneal dialysis, mayo partnership. Unique software development launches 3d printing initiative to beat coronavirus. Baxter international said tuesday that it will launch its amia automated peritoneal dialysis system in the u. Baxter receives 510 k clearance from fda for vlink with vitalshield, new antimicrobial intravascular technology baxter healthcare corporation recently announced that it received 510 k clearance from the u. Baxter wins fda 510k clearance for peritoneal dialysis. Baxter healthcare corp has received clearance from the fda on its colleague infusion pump 510 k premarket notification. Food and drug administration fda has indicated that the. Expands biosurgery product portfolio with fda 510 k marketing clearance for tricos t bone void filler read this article along with other careers information, tips and advice on biospace. Baxter has launched prismax in more than 20 countries across europe and australia, and expects to file for regulatory approval of prismax in additional countries in 2019 and 2020. Bax, a global leader in clinical nutrition, today announced the u. July 25, 2019 baxter healthcare corp gambro uf solutions. Baxter gets fda approval for prismax system and thermax.
Patients and providers rely on baxter for lifesaving renal and medical. Baxter receives 510k clearance from fda for colleague. Baxter received 510 k clearance for the use of altapore as an autograft extender in posterolateral spine in august 2018. Baxter baxter launches peristrips dry with secure grip. Bax announced today the united states food and drug administration fda has granted 510 k clearance for the amia automated peritoneal dialysis apd system with the sharesource webbased remote connectivity platform to provide peritoneal dialysis pd for the treatment of endstage renal disease esrd. The us food and drug administration fda recently approved the first pill to combine three. Baxter wins health canada nod for amia peritoneal dialysis system. September 2019 510 k clearances skip to main content. Global healthcare leader, baxter, recently gained 510 k clearance from the food and drug administration fda to market its next generation sigma spectrum infusion system, a compact electronic device integrally designed for the safe and accurate delivery of fluids and intravenous iv medications.
Food and drug administration for a new generation of its peristrips dry with veritas collagen matrix psdv product, known as psdv with secure grip. Now available with peel and secure technology, psdv is a staple line reinforcement material that bariatric. Baxter sent urgent device correction letters dated 32906 to those customers who had their renalsoft and renal software suite software configured with the affected modules. Following conclusion of the trial and study reporting process, baxter expects to submit a new drug application nda for the concentrates and 510 k for the device to the fda. Baxter gains fda 510k clearance for next generation. Searchable database of fda 510 k applications and descisions. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. Baxter said it is working to correct the problem and has developed and is validating a software modification to address this issue and plans to submit a 510 k. Bax, a leading global medical products company, announced it has submitted the prismax system for 510 k clearance to the u. Baxter wins ce mark for home dialysis device massdevice. Every day, millions of patients and caregivers rely on baxter s leading portfolio of critical care, nutrition, renal, hospital and surgical products. Altapore bioactive bone graft is the latest addition to baxter s growing osteobiologics portfolio of surgical products, which includes actifuse shape, actifuse mis, actifuse abx and actifuse flow. For safe and proper use of the devices mentioned herein, refer to the complete instructions in the operators manual. Fda has granted 510 k clearance for the amia automated peritoneal dialysis apd system with the sharesource web.
Baxter received guidance from the fda clarifying the regulatory pathway for an. New technology made possible by baxters leadership in dialysis, drug. Bax, a global leader in advancing surgical innovation, announced 510 k. Bax, a global leader in advancing surgical innovation, announced 510 k clearance from the u. Checker software for use in the european union and some affiliated nations in europe. Baxter launches ondemand peritoneal dialysis solution device trial. Gem flowcoupler system baxter synovis micro companies al510 k no. Baxter gets 510k clearance for nextgen infusion pump. Food and drug administration fda for its vlink lueractivated device lad with vitalshield protective coating. Baxter wins 510k clearance from the fda for its amia automated peritoneal.
Baxter renal software suite renal link and pd link. Baxters leading portfolio of critical care, nutrition, renal, hospital and surgical. Baxter receives 510k clearance from fda for vlink with. Staple line reinforcement helps mitigate bleeding during bariatric and other procedures staple line bleeding can cause significant complications for patients new format of peristrips dry is made from same biologic material but is two times faster to prepare than the previous version baxter international inc. The food and drug administration fda has indicated that the. Deciding when to submit a 510k for a software change to. Content of premarket submissions for software contained in.
Baxter gets 510 k clearance for nextgen infusion pump analyst blog. Baxter s ondemand solution technology is an investigative product and not approved for use. Class 1 recall for homechoice pd cycler home dialysis. Deciding when to submit a 510 k for a software change to an existing device guidance for industry and food and drug administration staff october 2017. Do not distribute without prior approval the proposed device prismax, which is the subject of this traditional premarket notification 510 k, consists of the prismax control unit.
Class 2 device recall baxter renal software suite for windows. Baxter achieves regulatory milestone for new peritoneal dialysis. Compact, portable monitor that accurately measures patients resting energy expenditure to help optimize nutrition therapy. Baxter plans to launch the vlink device with vitalshield coating int. The device intended for use with endstage renal disease patients contains the sharesource webbased remote connectivity platform, allowing physicians to remotely access their home patients.
The company is encouraging its customers to register with the fda so they can join. The device software on the prismax has been implemented correctly. Fda 510k applications for medical device product code. The company has started the process of packaging inventories carrying the new fdaapproved labeling and expects to start selling product in the united states by yearend. Fda 510k applications submitted by baxter healthcare. Baxter healthcare corporation, mcgaw park, illinois 60085. Fda issues class 1 recall for baxter dialysis machines. Baxter international has secured 510 k clearance from the us food and drug administration fda for prismax system and integrated thermax blood warmer, the nextgeneration platform for continuous renal replacement therapy crrt and therapeutic plasma exchange tpe.
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