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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.
 
DeviceESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM
Classification Nametranscervical contraceptive tubal occlusion device
Generic Nametranscervical contraceptive tubal occlusion device
Regulation Number884.5380
Applicant
BAYER PHARMA AG
mollerstrabe 178
berlin 13353
PMA NumberP020014
Supplement NumberS019
Date Received06/30/2008
Decision Date10/08/2008
Product Code
HHS[ Registered Establishments with HHS ]
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 contract sterilization site located at sterigenics us, inc. , santa teresa, new mexico.
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