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. 11680W Alcon Laboratories, Inc., Fort Worth, TX, June 27, 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 claims made in print ads for Alcon's Viscoat Viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics" Solution were "misleading" in that the ads referred to an article entitled "A Comparison of Corneal Endothelial Changes After Use of Healon or Viscoat During Phacoemulsification phacoemulsification /phaco·emul·si·fi·ca·tion/ (-e-mul?si-fi-ka´shun) a method of cataract extraction in which the lens is fragmented by ultrasonic vibrations and simultaneously irrigated and aspirated. ." The agency noted Viscoat had not received approval to claim superiority over the Pharmacia product. 11681W Candela Corp., Wayland, MA, June 27, 2001 (CDRH-OC). The letter objected to the firm's continued implications that its Candela Mid IR diode laser (aka "Smoothbeam") could be used for skin rejuvenation, removal of wrinkles and cosmetic purposes. While the company's response to the agency's previous April 16, 2001, letter (Doc. 11558W) was deemed by FDA as favorable, the letter clarified that not only before and after photos needed to be removed from the firm's website but all claims not cleared by the agency needed to be revised. Web 11682W J.D. Marvel Products, Inc., Champlain, NY, June 27, 2001 (CDRH-OC). After reviewing the firm's advertisement for its Super Mini Ear, the agency determined that the device is a hearing aid rather than an "assistive listening" device and needed to be marketed as such. The agency cautioned the firm that it needed to ensure that customers were evaluated by a licensed physician to show hearing loss prior to purchase. 11683W Stoelting Company, Wood Dale, IL, July 6, 2001 (CDRH-OC). A Jan. 3-9 inspection of the firm by Chicago District investigator Jesse Vasquez revealed the firm was marketing its A620 Electroencephalograph e·lec·tro·en·ceph·a·lo·graph n. An instrument that generates a record of the electrical activity of the brain by measuring electric potentials using electrodes attached to the scalp. biofeedback device for the treatment of Attention Deficit Disorder attention deficit (hyperactivity) disorder (ADD or ADHD) formerly hyperactivity Behavioral syndrome in children, whose major symptoms are inattention and distractibility, restlessness, inability to sit still, and difficulty concentrating on one thing for any (ADD) and Attention Deficit Hyperactivity Disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity. (ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ) when the device was 510(k)-cleared for relaxation training only. While the firm promised to destroy all print promotional materials, the agency found the firm was still marketing the ADD/ADHD claim on its Web site. The firm had received warning letters for this off-label marketing both on June 6, 2001 and Jan. 13, 1993. Web 11684W Sulzer Carbomedics, Inc., Austin, TX, July 6, 2001 (CDRH-OC). Review of the firm's Web site revealed Sulzer describing safe and effective use of its SEALPTFE vascular prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb. prosthesis Artificial substitute for a missing part of the body, usually an arm or leg. coated with an antibiotic when such use of the graft was not approved in the U.S. Web |
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