CDRH promo untitled letters.

The following untitled letters were issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC) in 2002. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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AmeriMark Direct, Cleveland, OH, Jan. 28, 2002 (CDRH-OC). FDA stated the firm, which distributes the Super Mini Ear, must secure a waiver signed by a physician before it can sell the device. The letter followed an agency review of an advertisement for the product in an October 2001 issue of "American Legion," determining that the device was a hearing aid and needed to be marketed as such.

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Computer Motion, Inc., Goleta, CA, Jan. 30, 2002 (CDRH-OC). The agency took issue with materials it obtained at an October 2001 American College of Surgeons meeting in New Orleans for its Zeus Robotic Surgical System. The materials claimed that the Zeus was "cleared for laparoscopic and thoracoscopic procedures." The agency reminded the firm that the device was only cleared to "assist" in these procedures and that in the "absence of this limitation, CMI implies that Zeus' cleared use is not to facilitate surgery, but that it is cleared to actually perform the procedures."

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Guidant, St. Paul, MN, Jan. 29, 2002 (CDRH-OC). FDA stated that Guidant could not promote a device in the U.S. that had a pending PMA. The promotional material the agency objected to was for the firm's ICD with Dual-Chamber Pacing defibrillators that mentioned the CONTAK CD as being approved for European use. The agency stated that Guidant "cannot promote a device that has not yet received clearance in the United States," and that the "use of disclaimers does not change the character of the material as being a claim for an uncleared or unapproved use."