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PMA Application
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First Module of PMA Application to FDA for Its Venaseal System Was Submitted by Sapheon
Sep 24, 2013US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease. This ...
Tags: PMA Application, Medicine
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Enteromedics Submitted Pma Application to US FDA for Maestro Rechargeable System's VBLOC
Jul 30, 2013EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
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Cerus's PMA Application Shell for Intercept Blood System Has Reviewed by FDA
Apr 26, 2013Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA). The PMA application shell accepted by the FDA for the ...
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PneumRx Has Treated The First US Patient in a FDA-Approved RENEW Clinical Study
Feb 28, 2013PneumRx has treated the first US patient in a FDA-approved RENEW clinical study of its RePneu lung volume reduction coil (LVRC), designed to treat severe emphysema. Made from shape-memory Nitinol, the CE-marked minimally invasive medical ...
Tags: PneumRx, lung volume reduction coil, FDA
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FDA Clearance for Single-Use Organ Preservation Device Is Got by Paragonix
Feb 19, 2013The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification (PMA) application of Paragonix Technologies' single-use organ preservation device Paragonix Sherpa Pak Cardiac Transport System (CTS). The CTS helps ...
Tags: FDA, PMA, Paragonix Technologies, CTS
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Vagal Blocking Therapy Is The Reason of Enteromedics Announces Study
Feb 18, 2013EnteroMedics has reported ReCharge study results of its VBLOC vagal blocking therapy, designed for the treatment of obesity. The pacemaker-like Maestro system delivers VBLOC therapy via two small electrodes that are laparoscopically ...
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Ablatherm-Hifu Device Pma Application with FDA Is Filed by EDAP
Feb 5, 2013EDAP TMS has filed a pre-market approval (PMA) application with the US Food and Drug Administration (FDA) for approval of its non-invasive, fully robotic Ablatherm-high intensity focused ultrasound (HIFU) device, designed to treat patients ...
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Patient Enrollment for IN.PACT Admiral Drug-Eluting Balloon Study Is Completed by Medtroni
Jan 28, 2013Medtronic has completed patient enrollment in controlled, multicenter, prospective IN.PACT SFA II clinical trial of its IN.PACT Admiral drug-eluting balloon device for treating patients with peripheral artery disease in the superficial ...
Tags: drug, Medtronic, eluting balloon study
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FDA Has Cleared PMA Application of Medstream Programmable Infusion System
Dec 18, 2012The US Food and Drug Administration (FDA) has cleared Codman & Shurtleff's pre market approval (PMA) application of Medstream Programmable Infusion system, designed as a treatment for spasticity caused by stroke, cerebral palsy, multiple ...
Tags: FDA, Medstream Programmable Infusion system, Medstream system
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FDA Clears VuCOMP's PMA Application for New Version of M-Vu CAD System
Dec 17, 2012The US Food and Drug Administration (FDA) has cleared VuCOMP's premarket approval (PMA) application for new version of M-Vu computer-aided detection (CAD) system. The new CAD system, M-Vu version 2, is designed for use in digital ...
Tags: FDA, CAD system, clinical technology
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ParadigmSpine Obtains PMA for Motion Preserving Interlaminar Stabilization Device From FDA
Dec 17, 2012ParadigmSpine has obtained premarket approval (PMA) for its motion preserving interlaminar stabilization device from the US Food and Drug Administration (FDA). The minimally invasive coflex device is designed for treating moderate to ...
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NuVasive Gains PMA for Its Cervical Motion Preserving System From FDA
Dec 17, 2012NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA). The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for ...
Tags: cervical motion preserving system, PCM cervical disc device, FDA
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Globus Obtains PMA From FDA for Articulating Intervertebral Disc Replacement Device
Dec 17, 2012Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between ...
Tags: FDA, articulating intervertebral disc replacement device
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Colorectal Cancer Screening Test First Module PMA Has Been Submitted to FDA
Dec 11, 2012Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration(FDA)the first module of the premarket approval(PMA)application for its stool DNA colorectal cancer screening test. The first modular ...
Tags: molecular diagnostics, Exact Sciences, PMA application
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Using Blood Samples, Instead of Stool Samples, Non-Invasive Epi ProColon Test Screens CRC
Dec 10, 2012Epigenomics has reported positive results from a clinical study, which showed that its blood-based colorectal cancer (CRC) detection test is non-inferior in sensitivity when compared to fecal immunochemical testing (FIT). Using patients ...
Tags: Epigenomics, blood-based colorectal cancer, non-inferior in sensitivity
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