Inspections, Compliance, Enforcement, and Criminal Investigations
Abbott Vascular, Inc. 19-Dec-07
Department of Health and Human Services
Public Health Service
Center for Devices and
DEC 19 2007
TRANSMITTED BY FACSIMILE
Abbott Vascular, Inc.
3200 Lakeside Drive
Santa Clara, California 95054
Dear Mr. Foltz:
The Office of Compliance (OC) of the Center for Devices and Radiological Health (CDRH) has learned that your firm promoted your Absolute® Biliary Self-Expanding Stent System (Absolute biliary stent) for use in the vasculature at the Vascular Interventional Advances conference, VIVA 07, held September 25-28, 2007, in Las Vegas, NV. Upon our request, on September 26, 2007, you provided the Office of Compliance with a copy of your promotional panel that was on display at the conference. This panel promotes your Absolute biliary stent for use in the vasculature. Under section 201(h) of the Act, 21 U.S.C. 321(h), the Absolute biliary stent is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing clearance or approval for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country.
FDA has reviewed your promotional panel for the Absolute biliary stent which you displayed at the September 2007 VIVA conference. The promotional panel for the Absolute biliary stent states "[a]dvancing vascular care." It also lists "Endovascular," "Coronary," "Vessel Closure," and "Carotid" next to "Biliary." These statements promote the Absolute biliary stent for use in the vasculature. This intended use requires submission of an application for premarket approval (PMA) under section 515 of the Act, 21 U.S.C. 360e.
A review of our records reveals that you did not obtain premarket approval from FDA before you began offering your Absolute biliary stent for use in the vasculature. Your 510(k), K033393 (cleared November 10, 2003), was cleared for the intended use of palliation of malignant strictures in the biliary tree. The device was required to bear a warning stating that the safety and effectiveness of the device for use in the vascular system has not been established.
Your promotion of the Absolute biliary stent for this unapproved indication renders it adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)( I)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency (21 U.S.C. 807.81(b)). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
It is your responsibility to ensure that all of your promotional materials for your Absolute biliary stent, and all your medical devices, are in compliance with each applicable requirement of the Act and FDA implementing regulations.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
The Office of Compliance (OC) requests that Abbott Vascular, Inc. immediately cease the display and dissemination of any promotional materials for Absolute biliary stent that includes the intended use described above. We acknowledge that pursuant to our request during a September 27, 2007, conference call with OC, you removed the Absolute biliary stent promotional panel that was on display at the VIVA conference. We also acknowledge receipt of your letter, dated October 5, 2007, responding to our concerns of your off-label promotion for this product that we expressed to you during our call. You state in your letter that you have removed the above-described statements in the promotional material for your Absolute biliary stents. However, your letter fails to state what further corrective actions you have taken to prevent the recurrence of this violation and to ensure that all of your medical devices are being promoted in accordance with the applicable requirement of the Act and FDA implementing regulations.
Please submit a written response within fifteen (15) working days of receipt of this letter, describing your intent to comply with this request, listing all promotional materials for Absolute biliary stents the same as or similar to those described above, and explaining your plan for discontinuing use of such materials, and your corrective action plan to prevent the recurrence of this violation of the Act. Please direct your response to Paul Tilton, Branch Chief, Ob/Gyn, Gastroenterology, and Urology Devices Branch, at the Food and Drug Administration, 9200 Corporate Boulevard, HFZ-332, Rockville, Maryland 20850. If you have any questions about the content of this letter, please contact Mr. Paul Tilton at 240-276-0115 or by facsimile at (240) 276-0114.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and