-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CX7hW3fHj4VlhVbPulg/EBeG/FkgqGpwyNBTvzOB4Pil+o2Ll7zuPZqWX4fTf6It 0naxkxV3vmtmR9KNb3dwew== 0001193125-06-228436.txt : 20061108 0001193125-06-228436.hdr.sgml : 20061108 20061108164121 ACCESSION NUMBER: 0001193125-06-228436 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20061108 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20061108 DATE AS OF CHANGE: 20061108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 061197988 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 d8k.htm FORM 8-K Form 8-K

UNITED STATES

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: November 8, 2006

(Date of earliest event reported)

 

ABIOMED, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware   04-2743260

(State or other Jurisdiction

of Incorporation)

  

(IRS Employer

Identification Number)

0-20584

(Commission File Number)

22 Cherry Hill Drive

Danvers, MA 01923

(Address of Principal Executive Offices, including Zip Code)

(978) 777-5410

(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:

 

¨ 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 7.01 Regulation FD Disclosure

Abiomed, Inc. currently plans to adopt a 510(k) strategy for the Impella® 2.5 minimally invasive circulatory support system. The Company notes that there are no guarantees that a 510(k) submission will be cleared by the FDA or the timing of such clearance should it occur. If the Company does not obtain 510(k) clearance, its PMA FDA strategy will continue with multiple pivotal centers. The information contained in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Act of 1934, whether made before or after the date hereof and regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.

 

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/ Daniel J. Sutherby

  Daniel J. Sutherby
  Chief Financial Officer

Date: November 8, 2006

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