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  1. Only showing results from fda.report

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  2. TOPAS™ Treatment for Fecal Incontinence . PMA P140006 . Sponsor Executive Summary . For the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee . MEETING DATE 25 FEB 2016 . ASTORA Women's Health, LLC . CONFIDENTIAL UNTIL FINAL . TOPAS System Panel Pack DRAFT Version 14 Jan 2016 .
  3. TOPAS™ System: Safety Information Cynthia L. Long, M.D. FACS Division of Reproductive, Gastro- Renal, and Urological Devices . Office of Device Evaluation . Center for Devices and Radiological Health . February 25, 2016 . 1 . TOPAS Implantation • Bilateral Perianal Incisions, 2-cm lateral and 3-cm
  4. TOPAS Overview • New, innovative, minimally invasive approach for women with Fecal Incontinence (Fl) • Uses surgical mesh to safely support a woman's natural anatomy Reduces episodes of Fl Improves patient quality of life • Not placed transvaginally . co-4 A Debilitating Condition
  5. • Existence of a report does not establish causation • Rates of occurrence cannot be established with reports . 19 KEY PARTS OF DASHBOARD Selected filter criteria. Filter panel. Navigation panel. Main Dashboard Page. Provides an option to search adverse event by product. View Disclaimer. Provide feedback on the dashboard.
  6. When final, this guidance will represent FDA's current thinking on this topic, available at . ... Format: [stakeholder] [form or document type] 119 Examples: [prescriber] [letter] prescriber-letter 120 [pharmacy] [enrollment form] pharmacy-enrollment-form 121 b. A stakeholder does not need to be specified for documents that are targeted to
  7. Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) documents and are defined in Section IV of this guidance. 2. Currently, the Center for Biologics Evaluation and Research does not regulate devices of the types subject to this guidance. 3. Pub. L. 115-52 . 4. See section 523(a)(3)(B) of the FD&C Act. 5
  8. final container of all parenteral preparations should be inspected to the extent possible for the presence of observable foreign and particulate matter (hereafter termed visible particulates) in its contents. The inspection process should be designed and qualified to ensure that every lot of all parenteral preparations is
  9. When final, this guidance will represent the FDA's current thinking on this topic. 2 . II. BACKGROUND . The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman Amendments) created an abbreviated approval pathway for duplicates of a
  10. FDA.report › GUDID › Aesculap AG › 04038653376346. Orthopaedic prosthesis implantation instrument, reusable. Primary Device ID: 04038653376346: NIH Device Record Key: 37eed893-fe07-4d0b-be6e-76ab0157c531: Commercial Distribution Status: In Commercial Distribution: Brand Name: COLUMBUS CR/PS: Version Model Number: NQ525:

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