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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 NumberS015
Date Received09/05/2024
Decision Date12/03/2024
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
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 revising the Instructions for Use (IFU) for the Filshie Clip to harmonize IFU labeling internationally.
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