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To: Stroke who wrote (1987)5/6/1999 11:18:00 PM
From: whyretire  Respond to of 2662
 
SMPX news biz.yahoo.com

excerpt from press release:

Symphonix Devices, Inc. Reports First Quarter Financial Results
SAN JOSE, Calif., May 6 /PRNewswire

In the United States, Symphonix reported that it expects to complete follow-up of its pivotal trial of the Vibrant P soundridge during the second quarter of 1999. Harry S. Robbins, Symphonix Chief Executive Officer, stated, ''We have now submitted to the FDA, under the modular PMA process, a total of seven modules, five of which have already been reviewed and accepted by the FDA.''

Symphonix also announced that it had received FDA approval of an IDE supplement permitting the evaluation of the Vibrant D soundbridge, the Company's latest generation product incorporating 100% digital technology . Harry S. Robbins stated, ''After fitting the device to many of our existing patients, the initial results from the Vibrant D soundbridge have been encouraging and we anticipate being able to submit data for the Vibrant D and Vibrant P soundbridges simultaneously to the FDA in a PMA submission.''