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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.
 
DeviceTHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Classification Namecatheter, balloon, transcervical
Generic Namecatheter, balloon, transcervical
Applicant
GYNECARE, INC.
p.o. box 151
sommerville, NJ 08876-0151
PMA NumberP970021
Supplement NumberS006
Date Received11/08/2002
Decision Date05/07/2003
Product Code
MKN[ Registered Establishments with MKN ]
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 A MATERIAL CHANGE TO THE SILIXONE BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.
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