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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHERMA CHOICE UTERINE BALLOON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE, INC.
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 - component
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.
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