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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.
 
DeviceGYNECARE THERMACHOICE 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 NumberS012
Date Received12/17/2004
Decision Date01/03/2005
Product Code
MKN[ Registered Establishments with MKN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD.
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