|
|
Article: CDRH promo untitled letters.
- Article from:
- Warning Letter Bulletin
- Article date:
- February 10, 2003
CopyrightCOPYRIGHT 2003 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
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.
12217W
American Medical Systems, Minnetonka, MN, Apr. 29, 2002 (CDRH-OC). Concerning the company's Model 700 Inflatable Penile Prosthesis, the agency expressed concern that an adverse event chart comparing the Model 700 with the Alpha-1 prosthesis made by Mentor, had been disseminated to a physician at a trade show. FDA warned AMS that there had been no comparative studies of the two devices.
12218W
...
Related newspaper, magazine, and journal articles:
|
|
Article: CDRH UNTITLED LETTERS: 7640W.
Warning Letter Bulletin;
May 31, 1999 ;
384 words
...London International Group, Dothan, AL, June 12, 1998 (CDRH-OC). FDA noted that the company's subsidiary, Regent Medical Products, had agreed to stop distributing literature making prohibited ...
|
|