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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 Nameinsert, tubal occlusion
Generic Nameinsert, tubal occlusion
Regulation Number884.5380
mollerstrabe 178
berlin 13353
PMA NumberP020014
Supplement NumberS040
Date Received10/03/2013
Decision Date10/30/2013
Product Code
HHS[ Registered Establishments with HHS ]
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 patient information booklet to include additional information on risks of chronic pelvic pain and device migration.