CDRH PROMO UNTITLED LETTERS.The following untitled letters are the first in a series issued by the Promotion and Adver-tising 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. 11586W Alase, McLean, VA, May 10, 2001 (CDRH-OC). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. stated that Web site promotion of the firm's LightSheer pulsed diode array laser misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. the device. The agency cited claims that the device would "permanently eliminate a large section of hair follicles Hair follicles Tiny organs in the skin, each one of which grows a single hair. Mentioned in: Alopecia " and that "subsequent visits will eliminate most of the remaining hairs that were dormant" during prior visits. The laser was cleared for "stable, long-term hair reduction in skin types I-IV through selective targeting of melanin melanin (mĕl`ənĭn), water-insoluble polymer of various compounds derived from the amino acid tyrosine. It is one of two pigments found in human skin and hair and adds brown to skin color; the other pigment is carotene, which contributes in hair follicles." FDA reminded the firm that the agency had sent the firm an Aug. 10, 2000, letter dealing with similar off-label claims. Web 11587W American College of Addictionology and Compulsive Disorders, Miami, FL, June 4, 2001 (CDRH-OC). FDA took issue with two newspaper stories that quoted one of the college's doctors as promoting the Moyco Industries Integrator device for the treatment of vertebral subluxation when it is not cleared for that use. 11588W Bausch & Lomb, Rochester, NY, May 7, 2001 (CDRH-OC). A review of the firm's Web site found B&L promoting the "piggyback" use of its Extended Range polymethylmethacrylate (PMMA PMMA polymethyl methacrylate. ) intraocular lenses (IOLs), FDA stated. Piggybacking is a technique involving putting two lenses of one power next to each other which the agency had not approved for the IOLs, according to the agency. The IOLs had been indicated for "primary implantation for the visual correction of aphakia" with supplements approving extended power ranges. The agency also found that only one advertised model fit with all of B&L's PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy supplements and requested the PMA annual report for other advertised models. Lab, Web 11589W Computerized Thermal Imaging, Inc., Layton, UT, April 26, 2001 (CDRH-OC). The letter followed up on a March 14, 2000, untitled letter stating the firm's Web site continued to promote its Photonic Stimulator and Thermal Image Processor for such conditions as chronic diabetic neuropathy, osteoarthritis of the knee, and chronic regional pain syndrome, when it was not cleared for them. Web 11590W CIBA Vision, Duluth, GA, May 8, 2001 (CDRH-OC). Press releases and ads for the firm's Dailies one-day contact lenses touting FDA recognition that the lenses were shown to reduce the occurrence of seasonal allergy conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an (SAC) were "misleading and inappropriate," the agency wrote. According to CDRH's Office of Device Evaluation, clinical trials for the lenses did not demonstrate any "clinically significant" differences in itching or objective measurements of redness. 11591W Davol, Inc., Cranston, RI, June 4, 2001 (CDRH-OC). The firm's Web site promoted its Ultrafoam collagen sponge as "unlike other hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik) 1. causing hemostasis, or an agent that so acts. 2. due to or characterized by stasis of the blood. he·mo·stat·ic adj. sponges on the market that require the addition of thrombin thrombin: see blood clotting. , a liquid clotting agent to control bleeding, the Ultrafoam sponge is made of Avitene, a natural clotting agent," a claim which the agency called "misleading." The absence of thrombin is not proven to suggest superiority, FDA said. Web 11592W Diomed, Inc., Andover, MA, June 4, 2001 (CDRH-OC). The letter stated that the firm's Web site promoted its lasers for Endovenous Varicose Vein treatment, an indication for which Diomed only had an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and at the time. The agency also took issue with the firm's "interventional radiology" claims, asking the firm to explain its use of the terms. In all, FDA questioned claims on 12 of the firm's Web pages. Web 11593W Dynatronics, Inc., Salt Lake City, UT, May 16, 2001 (CDRH-OC). Claims promoting the Synergie aesthetic therapeutic massager for subdermal sub·der·mal adj. Located or placed beneath the skin; subcutaneous. tissue massage and stretching did not fall under 510(k)-exempt claims for therapeutic massagers, FDA wrote to the firm. Such claims made on Dynatronics' Web site misbranded the device, the agency wrote, adding that it also required evidence for the massager's claim of providing "optimal stimulation." Web 11594W Hako-Med Electromedicine, Inc., Honolulu, HI, May 7, 2001 (CDRH-OC). The agency asked why the firm continued to make inappropriate claims about its ElecDT Horizon, ProElecDT 2000 and Vacupulls devices in promotional materials and on its Web sites. The letter followed one sent to the firm June 18, 1999. FDA noted that the ElecDT and ProElecDT 2000 were cleared for adjunctive use in post-traumatic pain syndromes, and not for the multiple claims listed by the firm. Web 11595W Interventional Technologies, San Diego, CA, May 25, 2001 (CDRH-OC). Three days after the firm indicated that promotion of its Cutting Balloon device for in-stent restenosis was "only distributed to international customers," the agency found a field service memo together with three peer-reviewed journal articles discussing instent restenosis and the device. The firm reminded Interventional that its balloon was only indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). perfusion in those circumstances where a high-pressure balloon resistant lesion is encountered. 11596W Lasersight Eyecare Medical Group, Santa Barbara, CA, May 11, 2001 (CDRH-OC). The letter noted that the firm marketed Sunrise's Hyperion LTK LTK Licence To Kill (James Bond Movie) LTK Language Toolkit LTK Lisp Tool Kit LTK Language Tool Kit laser for the correction of presbyopia Presbyopia Definition The term presbyopia means "old eye" and is a vision condition involving the loss of the eye's ability to focus on close objects. or "for the treatment of over-corrections resulting from LASIK LASIK laser-assisted in-situ keratomileusis. LA·SIK n. Eye surgery in which the surface of the cornea is reshaped using a laser, performed to correct certain refractive disorders such as myopia. treatments of myopia" when the device was indicated for temporary reduction of hyperopia. Additionally, FDA cited the medical group's Web site promoting the VISX' Star S3 and Autonomous' LADARVision lasers as being approved for treating "up to -14 diopters of myopia with up to 6 diopters of astigmatism and up to +6 diopters of hyperopia with up to 5 diopter Diopter A measure of the power of a lens or a prism. The diopter (also called dioptrie) is usually abbreviated D. Its dimension is a reciprocal length, and its unit is the reciprocal of 1 m (3.28 ft). astigmatism" when the Star S3 was approved for astigmatism only to -5 diopters, and the LADARVision was approved for hyperopia with up to 6 diopters of astigmatism. Web 11597W Millennium Laser Eye Centers, Sunrise, FL, May 7, 2001 (CDRH-OC). FDA took issue with the firm for pro-moting off-label LASIK in the "about procedures" heading of its Web site. The letter also stated that Millennium began to promote uses of excimer lasers following favorable advisory panel recommendations before official FDA approval of the PMA. Web 11598W Orthofix, Inc., McKinney, TX, May 16, 2001 (CDRH-OC). The letter took issue with an Orthofix Spinal-Stim promo entitled "Bone Growth Stimulation Bone Growth Stimulation Definition Bone growth stimulation is the technique of promoting bone growth in difficult to heal fractures by applying a low electrical current or ultrasound to the fracture. for Spinal Applications" comparing the device to competing products. FDA disagreed with parameters concerning the device's wear time, effectiveness on risk factors, surgical approaches, coverage areas technology, and points for consideration. The agency also took issue with the firm's claims that its device was "proven effective in smokers," citing that smoking patients were never studied in the device's clinical trial. 11599W Surgin, Inc., Tustin, CA, April 23, 2001 (CDRH-OC). FDA disputed claims made on the manufacturer's Web site that its Accublade microkeratome blade can be used interchangeably with blades other than the Chiron Vision Model ACS (Asynchronous Communications Server) See network access server. Keratome and Hansatome microkeratome. The agency reminded Surgin that its blade was approved only as a replacement for the two Chiron models. Web |
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