These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.
    Journal: Fed Regist; 2000 Sep 26; 65(187):57726-32. PubMed ID: 11503643.
    Abstract:
    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.
    [Abstract] [Full Text] [Related] [New Search]