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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
p.o. box 151
sommerville, NJ 08876-0151
PMA NumberP970021
Supplement NumberS002
Date Received02/03/1999
Decision Date11/02/1999
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications: 1) change in balloon material from latex to silicone; 2) addition of fluid circulation mechanism (i.e., impeller) within catheter; 3) change in software language from Assembly to a combination of C and Assembly; and 4) other minor modifications to the device system. In addition, changes also include a change in the manufacturer of the catheter controller to RELA, Inc., located at 410 S. Sunset, Bldg., D., Longmont, CO 80501. The device is intended for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.