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The ProVate Vaginal Support is indicated for the temporary, nonsurgical management of Pelvic Organ Prolapse in females.

The ProVate Vaginal Support is a vaginal ring pessary intended for the conservative nonsurgical, temporary management of Pelvic Organ Prolapse (POP) in females. The ProVate is a disposable, single use device intended to use for up to seven (7) days. The ProVate device is intended for prescription home use following a size fitting process performed by a health care professional. The device is supplied in its compact mode, within a disposable Applicator intended for the insertion of the device is expanded into its circular ring shape using the Applicator Plunger when inserting the device into the vagina. At the end of its use (up to 7 days), the patient pulls the Removal String which collapses the device into its compact configuration, facilitating easy removal. The device is then thrown away, and a new device can be inserted by the patient as needed. The ProVate includes additional components to facilitate insertion and removal of the device. The ProVate device is constructed to allow insertion into the vagina by the patient while the device is in a compact mode contained within a single use applicator. The ProVate device is expanded to its circular shape using the applicator when inserted into the vagina. Once inserted, the circular shape of the ProVate is comparable to that of the predicate device and the ring provides support to the prolapsed organs. To remove the device, the ProVate includes a removal string. Pulling on the string collapses the device to its compact state allowing for easier and more comfortable removal.