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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFEMCARE FILSHIE CLIP
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantFEMCARE LTD.
32 Premier Way
Romsey SO51
PMA NumberP920046
Supplement NumberS006
Date Received12/02/2008
Decision Date01/30/2009
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE SILICONE PROFILE OF THE DEVICE.
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