Cleared Traditional

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

K081710 · American Medical Systems · Obstetrics & Gynecology

Oct 2008

Decision

120d

Days

Class 3

Risk

About This 510(k) Submission

K081710 is an FDA 510(k) clearance for the APOGEE AND PERIGEE SYSTEMS WITH PC COATED 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 October 15, 2008, 120 days after receiving the submission on June 17, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5980.

Submission Details

510(k) Number	K081710 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2008
Decision Date	October 15, 2008
Days to Decision	120 days
Submission Type	Traditional
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