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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 NumberS011
Date Received04/12/2019
Decision Date10/09/2019
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site change for the Filshie Clip System Classic Applicator.
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