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FDA Managers Request 2nd Meeting with PDC Innovative.


Business Editors/Health & Medical Writers

CORAL SPRINGS Coral Springs, city (1990 pop. 79,443), Broward co., SE Fla.; inc. 1963. Largely residential, it is a city that has grown rapidly along with the southern Florida and Fort Lauderdale area. The population of Coral Springs nearly doubled between 1980 and 1990. , Fla.--(BUSINESS WIRE)--Sept. 11, 2001

PDC (1) (Primary Domain Controller) A Windows NT/2000 service that manages security for its local domain. Every domain has one PDC, which contains a database of usernames, passwords and permissions.  Innovative Industries Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:PDCI) management announced Tuesday that the Food & Drug Administration (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.
) management group who had viewed the demonstration of the Hypo-Pro 2000 decontaminater/compactor device on Aug. 23, 2001 requested another meeting before the company submits the 510(k) package for approval.

The purpose of the meeting would be to review the documentation from the various regulatory agencies regulatory agency

Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S.
 who will encounter the product, and the accompanying paperwork being prepared by Devices & Diagnostics Inc., the consultants who will prepare the 510(k) which will also include an operating manual and formal operating procedures for the medical personnel who will use the device.

In addition, prior to the submission of the 510(k), the FDA has also requested that prototypes be placed into two separate medical clinic locations and a survey protocol be established to garner comments on the device usage. Marketing Director Ron Epstein, president of Clearlake Financial Corp., Hialeah, Fla. stated he "welcomed" the request, would arrange the placements and will name the locations in the very near future. Michael Hiler, company chief operating officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
, who attended the first meeting stated that the company is "excited over FDA involvement and is taking seriously every instruction received so that upon completion of the 510(k) there will be little that has not been properly included."

Chief Executive Officer Harold Harris stated it is "certainly encouraging to know that management interest at the FDA appears to be directing the documentation progression in order to assist the company in preparing a tight 510(k) and as a consequence reduce the time needed for review."

Also announced was that the Independent Laboratory who would examine Hypo-Pro 2000 has been selected and that the testing protocol needed for the FDA had been established. Plant Manager Mark Blazer stated that a prototype has been selected for the laboratory, with the product ready to be sent within a week.

Also reported was that by direction of Home Depot The Home Depot (NYSE: HD) is an American retailer of home improvement and construction products and services.

Headquartered in Vinings, just outside Atlanta in unincorporated Cobb County, Georgia, Home Depot employs more than 355,000 people and operates 2,164 big-box
, headquarters Atlanta, Johnson Level & Tool Co., Wisconsin, was sent five different level types representing the products inventory at the Coral Springs facility. Home Depot management has asked that the company work with this prestigious group to integrate the levels product into a private labeling and to establish an exclusive product line from PDC Innovative for the Home Depot organization. PDCI management expects this format to be the basis for a continuing association with HD and is looking forward to introducing other products to HD in the future.

Hypo-Pro 2000, as the medical product is now called, is a container for use in a hospital, clinic or medical office location that remains with contaminated contaminated,
v 1. made radioactive by the addition of small quantities of radioactive material.
2. made contaminated by adding infective or radiographic materials.
3. an infective surface or object.
, disposable syringes and other smaller devices after use on a patient. The contaminants are subjected to high fahrenheit temperatures and then a compacting process which reduces the materials to the size of a U.S. quarter piece. The residual product a by product, as cotton waste from a cotton mill, coke and coal tar from gas works, etc.

See also: Residual
 after cycling in the container is decontaminated and is expected to be classified other than bio-hazardous waste. The container is expected to compete more than favorably fa·vor·a·ble  
adj.
1. Advantageous; helpful: favorable winds.

2. Encouraging; propitious: a favorable diagnosis.

3.
 against current bio-hazardous systems. One of the major, proprietary aspects of Hypo-Container 2000 is its portability and simple maintenance needs. There are currently no reported desktop decontaminating devices being used in the general medical environment. The Company is already planning larger versions of the same container for use during and after hospital surgeries where possible infectious waste could be more efficiently handled than current handling allows.

This press release contains forward looking statements made pursuant to the expression of future goals and similar expressions reflecting other than historical fact involves risks and uncertainties. The actual results the Company achieves may differ materially from any forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 due to such risks and uncertainties.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 11, 2001
Words:629
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