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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Tunica Albuginea who wrote (4010)	12/22/1997 6:07:00 PM
From: LoLoLoLita	Read Replies (1) \| Respond to of 23519

For the urologists here who don't read the Federal Register every week: --- [Federal Register: December 16, 1997 (Volume 62, Number 241)] [Proposed Rules] [Page 65770-65775] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16de97-15] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. 97N-0481] Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify the penile rigidity implant, a medical device intended to provide penile rigidity in men diagnosed as having erectile dysfunction, from class III to class II. The special controls identified in this proposed rule are the physician and patient labeling, biocompatibility testing, mechanical reliability performance testing, clinical testing, and sterilization requirements described in FDA's guidance document entitled ''Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.'' This reclassification is being proposed on the agency's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA). DATES: Written comments by March 16, 1998. FDA proposes that any final regulation based on this proposal become effective 30 days after its date of publication in the Federal Register. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194.

To: Tunica Albuginea who wrote (4010)	12/23/1997 5:41:00 AM
From: blankmind	Read Replies (2) \| Respond to of 23519

-- Does anyone know when the 12/15/97 short interest for VVUS will be known? -- Also, is there another site besides the one below to get this information as quickly as possible? viwes.com out.