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The CooperSurgical Milex™ pessaries are intended to provide support to pelvic organs when inserted in the vagina.

The following Indications for Use are associated with each of the following pessary styles:

Milex™ Incontinence Dish Pessaries and Incontinence Dish Pessaries with Support:
Incontinence dish pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.

Milex™ Cube Pessaries and Cube Pessaries with Drainage Holes:
Cube pessary is indicated for nonsurgical management of pelvic organ prolapse in Stage III prolapse including rectocele and/or cystocele.

Milex™ Incontinence Dish Pessaries, Incontinence Dish Pessaries with Support, Cube Pessaries, and Cube Pessaries with Drainage Holes are intended for support to pelvic organs when inserted into the vagina. Milex™ Pessaries are made of silicone and distributed in a non-sterile condition. The Milex™ Pessaries are available in a variety of styles, each having a range of sizes. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex™ Pessaries are manufactured in pink for single patient use.

This submission includes the following designs of Milex™ Pessaries: Incontinence Dish Pessary (Dish without Support, Dish with Support) and Milex™ Cube Pessary (Cube without Drainage Holes, Cube with Drainage Holes).

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