Exhibit 99.1
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| DEPARTMENT OF HEALTH & HUMAN SERVICES | | Public Health Service |
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| 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 |
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
