Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: November

Request Number: A-2016-000411

Request Summary: The reviewer’s comments and correspondence pertaining to the safety, efficacy, labelling and specifically the approval for Gynecare TVT abdominal Access system approved for use in Canada on January 4, 2002 on the transvaginal mesh products manufactured by Johnson & Johnson.

Disposition: Disclosed in part

Number of pages: 8

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