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dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...

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WOU001<br />

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=13208. Accessed June 30,<br />

2010.<br />

The NovaSure® Impedance Controlled Endometrial Ablation System (Hologic, Inc.) received<br />

premarket approval (PMA) on September 28, 2001 for ablation <strong>of</strong> the endometrial lining <strong>of</strong> the uterus<br />

in premenopausal women with menorrhagia due to benign conditions for whom childbearing is<br />

complete. See the following website for more information:<br />

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010013. Accessed<br />

June 30, 2010.<br />

The Microsulis® Microwave Endometrial Ablation (MEA) System received premarket approval<br />

(PMA) on September 23, 2003 for ablation <strong>of</strong> the endometrial lining <strong>of</strong> the uterus in premenopausal<br />

women with menorrhagia due to benign conditions for whom childbearing is complete. See the<br />

following website for more information:<br />

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P020031. Accessed<br />

July 1, 2010.<br />

The Cryo-Hit System (Galil Medical) first received 510(k) approval from the FDA on July 1, 1998.<br />

Modified versions <strong>of</strong> the device received 510(k) approval on July 12, 1999 and October 30, 2001. The<br />

device is intended for the cryosurgical destruction <strong>of</strong> tissue during gynecological procedures as well as<br />

in general, dermatological, neurosurgical, thoracic, oncological, rectal, and urological surgeries. See<br />

the following website for more information:<br />

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed June 30, 2010.<br />

Magnetic Resonance Imaging-Guided Focused Ultrasound<br />

The ExAblate 2000 System received premarket approval (PMA) on October 22, 2004 for ablation <strong>of</strong><br />

<strong>uterine</strong> fibroid tissue in pre- or perimenopausal women with symptomatic <strong>uterine</strong> <strong>fibroids</strong> who desire a<br />

<strong>uterine</strong> sparing procedure. See the following website for more information:<br />

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=3720. Accessed June 30, 2010.<br />

Levonorgestrel-Releasing Intra<strong>uterine</strong> Device<br />

MIRENA© received FDA approval on December 8, 2000 for use as an intra<strong>uterine</strong> contraceptive.<br />

Treatment <strong>of</strong> heavy menstrual <strong>bleeding</strong> for women who choose to use intra<strong>uterine</strong> contraception as<br />

their method <strong>of</strong> contraception was approved as an additional indication on October 1, 2009. See the<br />

following Web site for more information:<br />

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.<br />

Accessed June 25, 2010.<br />

Uterine Artery Embolization<br />

Uterine artery embolization (UAE) is a procedure and, therefore, not subject to FDA regulation.<br />

However, the embolic agents used are subject to FDA oversight. A number <strong>of</strong> agents are approved by<br />

the FDA for embolization procedures <strong>of</strong> the neurological system, but several have been specifically<br />

approved for UAE. See the following website for additional information (use product code HCG):<br />

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.<br />

Accessed June 25, 2010.<br />

Dysfunctional Uterine Bleeding & Uterine Fibroids Page 16 <strong>of</strong> 24

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