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Food and Drug Administration / Gynecological surgery / Female genital prolapse / Hernia / Premarket approval / Medical device / Federal Food / Drug / and Cosmetic Act / Colporrhaphy / Polypropylene / Medicine / Health / Technology


[removed]Federal Register / Vol. 79, No[removed]Thursday, May 1, [removed]Proposed Rules most recent fiscal year. Regardless of whether this proposed enforcement
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Document Date: 2014-05-07 17:08:54

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File Size: 276,59 KB

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City

Rockville / Baltimore / Washington / DC / /

Company

Ethicon Inc. / New England Journal / General Medical Co. / Social Security / /

Country

United States / /

Currency

USD / /

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Event

FDA Phase / /

Facility

Brazilian College of Surgeons / /

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IndustryTerm

individual mesh device / product development protocol / urogynecologic surgical mesh devices / prescription devices / preamendments device / marketed devices / data collection tools / Web site addresses / fixation tools / stand-alone mesh products / prescription device / stainless-steel needle / updated adverse event search / mesh products / erosion site / preamendments devices / repair device / /

MedicalCondition

atypical vaginal discharge / cystocele / Rectoceles / Neurological Disorders / sterility / uterine prolapse / urinary incontinence / leg pain / Pelvic Floor Dysfunction / vaginal discharge / injury / HEALTH RISK AND MITIGATION MEASURE FOR SURGICAL UROGYNECOLOGICAL MESH INSTRUMENTATION Identified risk Perioperative Injury / tissue contraction / pelvic abscess / de novo dyspareunia / illness / perioperative injury / rectocele / hernia / stress urinary incontinence / novo voiding dysfunction / pain / dyspareunia / infection / female stress urinary incontinence / /

MedicalTreatment

incision / general surgery / surgical treatment / surgery / catheter / surgeries / /

Organization

office of Medical Policy / International Continence Society / International Urogynecological Association / office of Management and Budget / U.S. Securities and Exchange Commission / Urogynecologic Surgical Mesh Instrumentation AGENCY / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / SOCIAL SECURITY ADMINISTRATION / FDA Public Health Notification / Center for Devices and Radiological Health / Division of Dockets Management / Brazilian College of Surgeons / Society of Gynecologic Surgeons Systematic Review Group / Transvaginal Pelvic Organ Prolapse Repair AGENCY / FDA / office of Regulations and Reports Clearance / Department of Health / /

Person

Carolyn W. Colvin / Leslie Kux / Brandon M. Belford / Silver Spring / Cheryl Williams / /

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Position

Secretary for reinstatement into the / Assistant Commissioner for Policy / Secretary / Governor / evaluator / Commissioner / representative / surgeon / Deputy Assistant Secretary for Aviation and International Affairs / Acting Commissioner / /

Product

Surgical Mesh / /

ProvinceOrState

Maryland / Kudish / Iglesia / /

PublishedMedium

New England Journal of Medicine / /

Technology

product development protocol / pdf / http / /

URL

http /

SocialTag