Cleared Special

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

K111118 · American Medical Systems · Obstetrics & Gynecology

Jul 2011

Decision

71d

Days

Class 3

Risk

About This 510(k) Submission

K111118 is an FDA 510(k) clearance for the AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, a Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III — Premarket Approval, product code OTP), submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on July 1, 2011, 71 days after receiving the submission on April 21, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5980.

Submission Details

510(k) Number	K111118 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2011
Decision Date	July 01, 2011
Days to Decision	71 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	OTP — Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 884.5980
Definition	Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally