Printer Friendly

BIOPLASTY WITHDRAWS SUBMISSIONS FILED WITH FOOD AND DRUG ADMINISTRATION

BIOPLASTY WITHDRAWS SUBMISSIONS FILED WITH FOOD AND DRUG ADMINISTRATION
 ST. PAUL, Minn., March 5 /PRNewswire/ -- Bioplasty, Inc. (NASDAQ-NMS: BIOP) announced today that it has withdrawn several applications filed with the Food and Drug Administration (FDA). These submissions are:
 -- Pre-Market Approval on MISTI(R) Single and Double Lumen silicone gel-filled implants.
 -- Investigational Device Exemption (IDE) on Uroplastique(TM) Micro- Implants used for the treatment of urinary incontinence.
 -- Investigational Device Exemption (IDE) on MISTI GOLD(TM) Bio- Oncotic(TM) Gel Mammary Prosthesis.
 Timothy Lawin, the company's president and CEO, stated that in view of the Advisory Panel's recommendation last month to severely restrict the use of silicone gel implants, the company has elected to withdraw its Pre-Market Approval (PMA) application submitted on July 8, 1991, for the company's silicone gel-filled implants. The withdrawal of the PMA renders the product no longer commercially available in the United States, and the company has ceased all export activity of silicone gel- filled devices from the United States.
 The company has decided to withdraw its Investigational Device Exemption (IDE) on Uroplastique Micro-Implants and MISTI GOLD Bio- Oncotic Gel Mammary Prosthesis to allow management to re-evaluate the contents of the submissions. After the re-evaluation is complete, the company intends to refile IDEs for both the Uroplastique Micro-Implants and the MISTI GOLD Bio-Oncotic Gel Mammary Prosthesis.
 Lawin further stated "We are committed to bringing the MISTI GOLD Bio-Oncotic Gel Mammary Prostheses to the U.S. market. We believe the MISTI GOLD Prosthesis with an alternative, non-silicone filling gel, helps address the concerns regarding silicone gel breast implants."
 Bioplasty, Inc. has more than 20 years of experience in the development, manufacturing and marketing of plastic surgery products worldwide. Bioplasty's stock is currently traded on the NASDAQ National Market System under the symbol "BIOP."
 -0- 3/5/92
 /CONTACT: Timothy P. Lawin of Bioplasty, 612-636-4112/
 (BIOP) CO: Bioplasty, Inc. ST: Minnesota IN: MTC SU:


AL -- MN008 -- 5484 03/05/92 13:17 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Mar 5, 1992
Words:323
Previous Article:PITTSBURGH TO BECOME USAIR'S NUMBER ONE CONNECTING HUB ON MAY 1
Next Article:USAIR TO FLY HARTFORD - ORLANDO
Topics:


Related Articles
INAMED BRINGS PATENT INFRINGEMENT SUIT AGAINST BIOPLASTY
FDA CALLS FOR A UNITED STATES MORATORIUM ON SILICONE GEL-FILLED BREAST IMPLANTS
BIOPLASTY PURSUES U.S. REGULATORY APPROVAL FOR UROPLASTIQUE(TM) FOR THE TREATMENT OF URINARY INCONTINENCE
BIOPLASTY SUBMITS INVESTIGATIONAL DEVICE EXEMPTION (IDE) FOR ITS MISTI GOLD BREAST IMPLANTS
BIOPLASTY WITHDRAWS BREAST IMPLANTS OVERSEAS
EPITOPE FILES ADDITIONAL INFORMATION WITH FDA FOR ORASURE PREMARKET APPROVAL APPLICATION
CARDIOPULMONICS REPORTS PMA SUBMISSION
QUEST MEDICAL ANTICIPATES MPS(TM) 510(K) FILING IN SECOND QUARTER 1995
SOMANETICS FILES 510(K) PRE-MARKET NOTIFICATION WITH FDA
Spectranetics Submits 'Pre-Market Approval' to FDA For Laser Device Used to Remove Pacemaker Leads

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters