UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: September 14, 2006
UROPLASTY, INC.
(Exact name of registrant as specified in charter)
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000-20989
(Commission File No.)
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41-1719250
(IRS Employer Identification No.) |
Minnesota
(State or other jurisdiction of incorporation or organization)
5420 Feltl Road
Minnetonka, Minnesota 55343
(Address of principal executive offices)
952-426-6140
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name and Address)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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o Written communications pursuant to Rule 425 of the Securities Act (17 CFR 230.425) |
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o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 8.01 Other Events
On September 13, 2006 we issued a press release announcing that we received an approvable letter
from the U.S. Food and Dug administration (FDA) relating to our pre-market approval (PMA)
application for Macroplastique Implants for the treatment of female stress urinary incontinence.
The receipt of the approvable letter follows FDA’s completion of the scientific review of the
safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable subject to
our manufacturing facilities, methods and controls being audited by the FDA and in compliance with
applicable Quality System Requirements. The FDA is currently auditing our manufacturing facilities
in Minneapolis, Minnesota and Eindhoven, The Netherlands.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
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| Exhibit No. |
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Description |
99.1
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Press Release dated September 13, 2006 (filed herewith). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: September 14, 2006
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UROPLASTY, INC.
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By: |
/s/ Mahedi A. Jiwani
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Mahedi A. Jiwani |
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Vice President, Chief Financial Officer and
Treasurer |
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