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[IP] Deltec, Inc. Receives 510k Clearance for Insulin Pump
- To: undisclosed-recipients:;
- Subject: [IP] Deltec, Inc. Receives 510k Clearance for Insulin Pump
- From: email @ redacted
- Date: Thu, 15 Aug 2002 14:42:46 EDT
- Reply-To: email @ redacted
<A HREF="http://www.businesswire.com/cgi-bin/f_headline.cgi?day0/222272277&ticker=">Deltec, Inc. Receives 510k Clearance for Insulin Pump</A>
BW2277 AUG 15,2002 9:01 PACIFIC 12:01 EASTERN
( BW)(MN-DELTEC) Deltec, Inc. Receives 510k Clearance for Insulin Pump
Business Editors & Health/Medical Writers
ST. PAUL, Minn.--(BW HealthWire)--Aug. 15, 2002--Deltec, Inc., the
Minnesota-based infusion pump manufacturer, part of Smiths Medical, has
received 510k clearance from the Food and Drug Administration (FDA) to allow
it to market its insulin infusion pump in the treatment of diabetes.
The new Deltec Cozmo(TM) insulin pump offers significant advantages over
currently available insulin pumps, most notably its ease of use and flexible
programming which allow people with diabetes to personalize their treatment
to meet their lifestyle demands. It is estimated that approx. six per cent of
the U.S. population has diabetes.
The pump is a small, lightweight, cell phone-size device worn by a person
with diabetes to deliver insulin continuously, day and night through a small,
short, flexible plastic tube that is inserted just under the skin and changed
every few days. Patient friendly features including a full-sized 300 unit
insulin cartridge, power by a single AAA battery, and a large, easy to read
display, are combined with over twenty years of Deltec's ambulatory pump
development and manufacturing experience.
"Deltec has a long history of developing high quality, reliable
ambulatory infusion pumps," said Jim Stitt, president of Deltec, "and we have
combined that expertise with the needs identified from people with diabetes,
certified diabetes educators, and physicians to develop a superior insulin
The Deltec Cozmo(TM) insulin pump also has many safety features that are
designed with pediatric use in mind, such as a Program Lockout that prevents
users from entering the menu, a Delivery Limit Alarm to limit the amount of
insulin that is delivered over an hour, and a Missed Meal Bolus Alert that
alerts the user if a meal bolus is not given.
Deltec has sold over 150,000 ambulatory infusion pumps worldwide, which
are used in a variety of infusion therapies to deliver medications for
chemotherapy, pain management, TPN, hydration, dialysis, and to deliver
antibiotics, treat primary pulmonary hypertension, eliminate excess iron,
prevent clotting, and produce blood cells. The ambulatory nature of Deltec
infusion pumps allows patients to maintain a better quality of life while
undergoing their therapy.
Headquartered in St. Paul, MN, Deltec is part of the Medical division of
Smiths Group plc, London and manufactures a wide range of infusion and access
systems for domestic and international markets. For additional information,
visit Deltec's web site at <A HREF="http://www.deltec.com/">www.deltec.com</A>.
--30--cr/ms*CONTACT: Deltec, Inc., St. PaulTerri Servais,
651/628-7248E-mail: <A HREF="mailto:email @ redacted">email @ redacted</A>orBrian Johnson,
651/628-7154E-mail: <A HREF="mailto:email @ redacted">email @ redacted</A>KEYWORD: MINNESOTA UNITED KINGDOM
INTERNATIONAL EUROPEINDUSTRY KEYWORD: GOVERNMENT MANUFACTURING MEDICALMEDICAL
DEVICES PHARMACEUTICAL PRODUCTSOURCE: Deltec, Inc.
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