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TriVascular

FDA awards PMA to Trivascular for Ovation abdominal stent graft

November 12, 2012 By MassDevice staff Leave a Comment

Travascular's Ovation stent graft system

Medical device maker Trivascular won premarket approval for its Ovation stent graft system, almost precisely 1 year after the FDA granted the device approval under the humanitarian use device pathway.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Vascular Tagged With: TriVascular

GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup

November 11, 2011 By MassDevice staff Leave a Comment

GE Healthcare's Senographe Essential

GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.

The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Biolase, Boston Scientific, Centers for Medicare and Medicaid Services (CMS), Cordis Corp., Cytomedix Inc., Diopsys Inc., Ethicon, Femasys Inc., Fresenius, GE Healthcare, Hologic, i-Optics, IDEV Technologies Inc., IntraPace Inc., Johnson and Johnson, Maquet Cardiovascular LLC, Nephros, Ozics Group, Regulatory Roundup, TriVascular, U-Systems, Verisante Technology

Stents: FDA approves TriVascular’s Ovation stent graft system | Regulatory Roundup

November 7, 2011 By MassDevice staff Leave a Comment

Trivascular

TriVascular Inc. landed U.S. humanitarian device exemption approval for its Ovation abdominal stent graft system used to repair abdominal aneurysms.

The 20 mm Ovation system was approved by the FDA on Nov. 1 for use in patients with small iliac or femoral artery access of less than 7 millimeters.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Clinical Trials, Guided Therapeutics Inc., IntraPace Inc., Regulatory Roundup, Sunshine Heart Inc., TriVascular

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