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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.
 
DeviceFilshie Clip (Mark VI) System
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantFemcare , Ltd.
32 Premier Way
Romsey SO51 9DQ
PMA NumberP920046
Supplement NumberS012
Date Received12/08/2021
Decision Date01/06/2022
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System.
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