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FDA REQUIRES CARDIOPULMONICS TO AMEND PMA SUBMISSION BEFORE FILING

 SALT LAKE CITY, Aug. 30 /PRNewswire/ -- CardioPulmonics Inc. (NASDAQ-NMS: CRDS) announced today that the United States Food and Drug Administration (FDA) has notified the company that its pre-market approval (PMA) application for its IVOX(R) intravascular gas exchange device is incomplete and will require an amendment addressing noted deficiencies before it can be accepted for filing or for further consideration by the FDA.
 The FDA recommended reanalysis of the company's collected clinical data, and collection and/or reporting of other data in several different areas. If certain of the clinical data cannot be reanalyzed or if the data requested by the FDA are unavailable, the FDA suggests that the company may need to consider redesign of a clinical study to provide for a randomized concurrent control group and collect clinical utility performance data for the IVOX.
 The company has 180 days to either file reanalyzed data as a PMA amendment or to request an extension. The company anticipates that it will be able to respond to a number of the FDA's requests in the time frame allowed. However, at this time the company is not certain that it will be able to respond adequately to other FDA requests without conducting additional clinical trials. The company is continuing to review and analyze the FDA response to determine appropriate future action.
 CardioPulmonics Inc. manufactures the IVOX device (Intravascular Oxygenator) that is being studied under the IDE (Investigational Device Exemption) from the FDA.
 -0- 8/30/93
 /CONTACT: William S. Barth, CFO, 801-350-3600/
 (CRDS)


CO: CardioPulmonics Inc. ST: Utah IN: MTC SU:

LM-BP -- LA021 -- 7231 08/30/93 17:00 EDT
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Publication:PR Newswire
Date:Aug 30, 1993
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