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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 NumberS010
Date Received11/18/2003
Decision Date12/02/2003
Product Code
MKN[ Registered Establishments with MKN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS.
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