VITAL HEART SYSTEMS REPORTS COMMUNICATION FROM FDA
VITAL HEART SYSTEMS REPORTS COMMUNICATION FROM FDA BEVERLY, Mass., Aug. 28 /PRNewswire/ -- Vital Heart Systems, Inc.
(NASDAQ: VHRT) reports that it has received an FDA warning letter claiming that the company did not have appropriate FDA clearance to market a product described as the Cherne Medical Chaos Analysis Machine.
Because the company is not marketing a product by that name, it is currently seeking clarification of the letter's intent and whether it applies to the company's current product. Vital Heart Systems, Inc. (formerly Cherne Medical) received FDA clearance to market its current product on Sept. 25, 1985, and as modified on April 23, 1986. Vital Heart Systems, with offices in Beverly and Minneapolis, manufactures and markets the Variance Cardiograph, a non-invasive, stress-free diagnostic instrument capable of identifying coronary artery disease even when no symptoms are present. The stock of Vital Heart Systems, Inc. is traded on the national over-the-counter market. -0- 8/28/92 /CONTACT: David L. Printy, chairman, president & CEO, or Deborah Meacock, director-investor relations of Vital Heart Systems, 800-966-2838/ (VHRT) CO: Vital Heart Systems, Inc. ST: Massachusetts IN: MTC SU:
AH-TM -- NY077 -- 4686 08/28/92 19:01 EDT
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|Date:||Aug 28, 1992|
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