SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES AND EXCHANGE ACT OF
Date of report (Date of earliest event reported): September 7, 2011
HANSEN MEDICAL, INC.
(Exact name of registrant as specified in charter)
|(State or other jurisdiction of incorporation)||(Commission File Number)||(I.R.S. Employer Identification No.)|
800 East Middlefield Road
Mountain View, California 94043
(Address of principal executive offices
and zip code)
Registrants telephone number, including area code: (650) 404-5800
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:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Item 8.01 Other Events
On September 7, 2011, Hansen Medical, Inc. (the Company) received a letter from the U.S. Food and Drug Administration (the FDA) responding to the Companys April 2011
submission of a 510(k) pre-market notification application for its Magellan(TM) Robotic System and NorthStar(TM) Robotic Catheter. The FDAs initial response indicates the 510(k) approach is an appropriate regulatory pathway for the
Companys vascular robotic system and does not include a request for additional clinical testing. The FDAs initial response requests the Company to answer certain questions regarding the application. The Company is continuing to review
the FDAs requests. The timing of the Companys response to the FDA has not been determined; and, therefore the timing of the FDAs evaluation of the Companys response is uncertain.
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, hereunto duly authorized.
HANSEN MEDICAL, INC.
|Date: September 9, 2011|
Peter J. Mariani