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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFILSHIE CLIP (MARK VI) SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantFEMCARE LTD.
32 Premier Way
Romsey SO51
PMA NumberP920046
Date Received09/10/1992
Decision Date09/05/1996
Product Code KNH 
Docket Number 96M-0463
Notice Date 12/09/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FILSHIE CLIP SYSTEM (MARK VI). THE DEVICE IS A CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD)
Supplements:  S005 S006 S007 S008 S009 S010 S011 S012 S013 
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