Medical Devices

OCT 29 2009


WARNING LETTER


Mr. Stefano Di Lullo
President, Sorin CRM Business Unit
Sorin Biomedica CRM, S.R.L.
Via Crescentino S.N.
13040 Saluggia (VC) Italy


Dear Mr. Di Lullo:

During an inspection of your firm located in Saluggia, Italy on June 29 through July 2, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Situs OTW Lead and lsoline 2CR Lead. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.