Pre-Market Approval Application


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Pre-Market Approval Application

An application to FDA for a licence to market a new device in the United States.
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US-based medical technology company Becton, Dickinson and Co (BD) (NYSE: BDX) has submitted a pre-market approval application to the US Food and Drug Administration for the BD Onclarity HPV Assay, its human papillomavirus test, the company said on Tuesday.
a developer of stents designed to treat coronary bifurcation lesions, has filed the final module of its Pre-Market Approval application with the US Food and Drug Administration for the Tryton Side Branch Stent, the company said on Monday.
NYSE: MDT) has submitted a pre-market approval application to the US Food and Drug Administration for the use of its SynchroMed II implantable drug infusion system (including a newly developed catheter) for use with US-based United Therapeutics Corp.
Such forward-looking statements, including those relating to the Company's cash position, and the timing and outcome of statistical analysis relating to CLOSURE I and the timing and outcome of the Company's submission of a Pre-Market Approval application with the U.
This process allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a pre-market approval application or a pre-market notification submission to FDA.
EnteroMedics remains in a good financial position, with cash reserves to fund operations through 2009, by which time we expect to have a pre-market approval application for VBLOC Therapy before the FDA.
The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.
Recently, Ortec International announced that it had submitted a Pre-Market Approval application to the Food and Drug Administration for the use of OrCel([R]), a bilayered cellular matrix of engineered tissue to heal chronic and acute wounds, in the treatment of Venous Leg Ulcers (VLU).
Edwards Lifesciences has submitted a Pre-Market Approval application to the United States Food and Drug Administration (FDA) and is currently responding to the Agency's follow-up questions.
be preceded either by a pre-market notification clearance order under section 510(k) of the Food, Drug and Cosmetic Act, or an approved pre-market approval application.
a Sorin Group (MIL:SRN) Company and a member of the Sorin Group Cardiac Rhythm Management (CRM) Business Unit, today announced that it has filed a pre-market approval application (PMA) with the United States Food and Drug Administration (FDA) seeking approval to market OVATIO[TM] CRT, its latest cardiac resynchronization therapy defibrillator (CRT-D).
Prior to filing of the Cerashield(TM) pre-market approval application, Ceragenix will request an expedited review by the FDA of the application.