UroQuest PMA submission for On-Command male urinary control catheter slated for later this year.
This article was originally published in The Gray Sheet
UROQUEST ON-COMMAND MALE URINARY CONTROL CATHETER PMA SUBMISSION is slated for the second half of 1997 following the completion of an ongoing controlled, randomized clinical study, the Salt Lake City-based company says. When UroQuest Medical (formerly Trek Medical) initiated the study in December 1996, the firm expected to use the data to support a 510(k) for On-Command; however, FDA has determined that premarket approval applications would be required for both male and female versions of the device, which are designed to treat voiding dysfunction (urinary incontinence or urinary retention).
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