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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.
 
Device FILSHIE CLIP(MARK VI) SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantFemcare , Ltd.
32 Premier Way
Romsey SO51 9DQ
PMA NumberP920046
Supplement NumberS008
Date Received06/09/2014
Decision Date12/02/2016
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the single use only Sterishot II Applicator.
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