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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.
 
Trade NameFEMCARE FILSHIE CLIP
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion
Regulation Number884.5380
ApplicantFEMCARE NIKOMED LIMITED
PMA NumberP920046
Supplement NumberS006
Date Received12/02/2008
Decision Date01/30/2009
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the silicone profile of the device.
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