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 2001. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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CeraMed Dental, L.L.C., Lakewood, CO, Oct. 18, 2001 (CDRH-OC). The agency took issue with a promotional flyer for the company's PepGen P-15 bone filling material which stated: "For additional containment of PepGen P-15 FLOW, a fast resorbing barrier membrane may be used (such as Gelfoam[R])." Since Gelfoam is a hemostatic agent which has not been cleared as a barrier membrane, FDA stated the parenthetical reference "changes the effectiveness of the PepGen P-15 device."

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Cornell Refractive Surgery Center, Pineville, NC, Nov. 26, 2001 (CDRH-OC). Newspaper ads and the center's Web site promoted the SLS Biophile NLite laser for "facial wrinkle reduction" representing "a major modification of the intended use of the device." The NLite is cleared for the treatment of periocular wrinkles. Also, an ad for Alcon's LADARVision excimer laser did not carry the required "brief statement of the intended uses for the device and relevant precautions, side effects and contraindications," FDA stated. O-L Use, Web

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Diamatrix Limited, Inc., The Woodlands, TX, Nov. 19, 2001 (CDRH-OC). A picture in an ophthalmology journal inappropriately characterized Diamatrix knives as "approved by the FDA for multiple use," the agency stated. As a Class I exempt device, the knives do not go through the premarket notification process and "should not be represented as such," the letter stated.

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EP Technologies, Inc., San Jose, CA, Nov. 26, 2001 (CDRH-OC). The agency objected to a brochure for EP's Cobra RF System which "clearly intended to demonstrate the use of the Cobra RF System for creating linear lesions in the heart and for coagulation of atrial tissue after cardiac ablation." Given the narrowing of an intended use to the heart specifically creates a new intended use for the device, the agency stated. PMA 

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GE Medical Systems, Milwaukee, WI, Oct. 16, 2001 (CDRH-OC). A review of the firm's Web site found that promotional material for GE's LightSpeed and HiSpeed CT scanners and software promote the devices for screening asymptomatic individuals for cardiac conditions, an off-label use, FDA stated. O-L Use, Web

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Idea Software, Frederick, MD, Oct. 22, 2001 (CDRH-OC). FDA took issue with claims on the firm's Web site that the Z'Strong bioelectric discharger it distributes can treat hypertension. The 510(k)-cleared device is indicated for providing visual or auditory feedback for muscle activity. The agency states the claims would nullify the device's current exemption and the company would be required to file a new 510(k). The letter also reminded Idea that the agency issued an Aug. 25, 2000, warning letter objecting to similar claims. 510(k), Web

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Marconi Medical Systems, Cleveland, OH, Oct. 16, 2001 (CDRH-OC). The letter stated that promotional material on the company's Web site for the Mx8000 CT scanner promoted the device for the screening of disease in symptomatic and asymptomatic patients, which FDA considers an off-label use. O-L Use, Web

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Millennium Laser Eye Center, McLean, VA, Oct. 23, 2001 (CDRH-OC). FDA took issue with the center's radio ad for the Sunrise Hyperion LTK excimer laser which stated: "Now, if you are farsighted and over 40 ... If you're over 40 and tired of reading glasses, we are proud to introduce LTK." The agency stated that LTK is meant to improve vision at a distance and not for improving the ability to see objects up close. Also, the center's ad for the LADARVision excimer laser did not carry a brief statement of the intended uses for the device as required, the letter stated. DTC 

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Scion Cardio-Vascular, Inc., Miami, FL, Oct. 5, 2001 (CDRH-OC). The letter stated a press release on the firm's Web site incorrectly implied its SciPro flexible stone dislodger and retrieval set was cleared for cardiovascular use when the device had been cleared for urological and/or gastrointestinal procedures. Similarly, the agency took issue with claims made for the firm's Clo-Sur Pad wound dressing, DuoClip surgical clip applier, and OneStent with Sleek Balloon. O-L Use, Web

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SEIRIN-America, Weymouth, MA, Nov. 26, 2001 (CDRH-OC). The agency stated the company was promoting its line of acupuncture needles in print materials and its Web site for "moxa therapy" and "electro-acupuncture." FDA explained that while the 510(k) for the needles intends them "for the general practice of acupuncture," the use of an electrical device with the needles makes them a Class III investigational device in need of a new 510(k).

Also, FDA cautioned that links on the Web site leading to acupressure point and stimulation instruments could be interpreted as off-label use. 510(k), O-L Use, Web

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Visual Health & Surgical Center, Lake Worth, FL, Nov. 20, 2001 (CDRH-OC). FDA wrote that the center's promotional materials and Web site tout the use of Allergan's ARRAY Multifocal Intraocular lens "for those over the age of 40 who want to reduce or eliminate the need for bifocals," when the device is indicated "for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed." Such claims count as off-label promotion, the agency stated. O-L Use, Web