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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.
 
DeviceSterishot II Mini Flishie Clip Applicator
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantFEMCARE LTD.
32 Premier Way
Romsey SO51
PMA NumberP920046
Supplement NumberS010
Date Received03/01/2017
Decision Date05/26/2017
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a variant of the tubal occlusion device introducer, Sterishot II Mini Filshie Clip Applicator.
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