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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.
 
DeviceCONCEPTUS ESSURE 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 NumberS020
Date Received07/23/2008
Decision Date09/11/2008
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to specifications of the dry flow introducer and the addition of a back-up bond in the detachment mechanism.
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