Cleared Special

K040521 - MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K040521 · American Medical Systems, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
23d
Days
Class 3
Risk

K040521 is an FDA 510(k) clearance for the MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 24, 2004 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5980 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K040521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2004
Decision Date March 24, 2004
Days to Decision 23 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 160d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class Class 3 - 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
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.