Cleared Special

K090934 - PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
(FDA 510(k) Clearance)

K090934 · American Medical Systems, Inc. · General & Plastic Surgery

Jun 2009

Decision

61d

Days

Class 2

Risk

K090934 is an FDA 510(k) clearance for the PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 2, 2009, 61 days after receiving the submission on April 2, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K090934 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2009
Decision Date	June 02, 2009
Days to Decision	61 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF