SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 19, 2013
ABIOMED, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware |
001-09585 |
04-2743260 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
22 Cherry Hill Drive
Danvers, MA 01923
(Address of principal executive offices) (Zip Code)
(978) 646-1400
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 (see General Instruction A.2. below).
| ¨ | 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 February 19, 2013, Abiomed received a close-out letter from the Food and Drug Administration, Office of Compliance with respect to its previous FDA warning letter dated June 10, 2011. The close-out letter states that the FDA Office of Compliance has completed its evaluation of the corrective actions taken by Abiomed in response to the previously disclosed FDA warning letter and that the concerns cited in that letter appear to have been addressed. A copy of the letter is attached as Exhibit 99.1 to this current report on Form 8-K and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| Number |
Description | |
| 99.1 | Letter to Abiomed from the FDA dated February 19, 2013. | |
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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.
| ABIOMED, Inc. | ||
| By: | /s/ Robert L. Bowen | |
| Robert L. Bowen Vice President and Chief Financial Officer | ||
Date: February 20, 2013
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Exhibit 99.1
| DEPARTMENT OF HEALTH & HUMAN SERVICES | Public Health Service | |||
| Feb 19, 2013 | Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 | |||
VIA UNITED PARCEL SERVICE
Michael R. Minogue
President and Chief Executive Officer
ABIOMED, Incorporated
22 Cherry Hill Drive
Danvers, Massachusetts, 01923-2575
| Re: | IMPELLA RECOVER LP 2.5 Percutaneous Cardiac Support System |
| Refer to: GEN1100068 |
The Food and Drug Administration has completed an evaluation of Abiomed, Inc.’s, corrective actions in response to our Warning Letter dated June 10, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/s/ Steven D. Silverman
Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health