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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.
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation system
ApplicantETHICON, INC.
PMA NumberP970021
Supplement NumberS043
Date Received09/02/2015
Decision Date10/02/2015
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the manufacturing process, "process specification for drive assembly, thermachoice catheters 3. 0," for the gynecare thermachoice balloon catheter. The changes include specifications for the pressure ranges of the crimp fixture and hex cap press fixture, specifications for the application of loctite 406, and a modification to the adhesive application process.