Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: September

Request Number: A-2016-000415

Request Summary: The reviewer’s comments and correspondence pertaining to the safety, efficacy, labelling and specifically the approval for Gynecare Prolift +M Pelvic Floor Repair Systems approved for use in Canada on September 8, 2008 on the transvaginal mesh products manufactured by Johnson & Johnson.

Disposition: Disclosed in part

Number of pages: 16

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