Cleared Special

AMS ELEVATE PC

K112842 · American Medical Systems, Inc. · Obstetrics & Gynecology

Oct 2011

Decision

26d

Days

Class 3

Risk

About This 510(k) Submission

K112842 is an FDA 510(k) clearance for the AMS ELEVATE PC, a Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III — Premarket Approval, product code OTP), submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 25, 2011, 26 days after receiving the submission on September 29, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5980.

Submission Details

510(k) Number	K112842 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2011
Decision Date	October 25, 2011
Days to Decision	26 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