WebJan 25, 2024 · Defendant is a designer, manufacturer, producer, and supplier of medical devices; in particular, Flowonix manufactured a programmable infusion pump and catheter, known as Prometra II (“Prometra” or “the Pump”) that can be implanted in a patient. Pls.' Amend. Compl. ¶ 7. WebPrometra Flowonix pump can cause fatal discharge of intrathecal pump medications in MRI (needs to have medications removed prior to MRI scan, and then refilled after) Medtronic Synchromed II pump (the one used at UCSF), is MRI compatible but will cause a stall during the MRI that will typically recover within an hour or two after the scan, but ...
Class 2 Device Recall Prometra II Programmable Infusion Pump
WebFlowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen. Flowonix introduced the Prometra II 40mL pump to the US market in November 2024, providing patients and clinicians a choice between 20 mL and 40 mL capacities … WebJan 5, 2024 · Flowonix’ Prometra II pump is indicated for intrathecal infusion of drug therapy. Flowonix intends to use the financing to clear the previous venture debt, along with funding its business plan, which includes development of new generation products, production line expansion, and collaborations with pharma companies. ... philosophers index montana state
Programmer Flowonix
WebSep 24, 2013 · The Prometra pump by Flowonix (Figure 3) is an implantable, programmable pump. It can be used to deliver a volume at different rates and is refilled percutaneously. The accuracy, efficacy, and safety of the Prometra pump was assessed in clinical trials, demonstrating an accuracy of 97.1%, with a 90% confidence interval of … WebJan 4, 2024 · "We look forward to a long-term and fruitful partnership with Flowonix," said Winston Black, CEO of SWK."The Company's Prometra II pump precisely delivers consistent dosing accuracy, proving to be ... WebMay 6, 2015 · MOUNT OLIVE, N.J., May 6, 2015 /PRNewswire/ -- Flowonix Medical, Inc., announced today that the first implants of its Prometra ® II intrathecal infusion pump took place on May 5, 2015 at St ... tsh charbonnier