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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.
 
DeviceFALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS017
Date Received11/02/2015
Decision Date07/20/2016
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 to recover and repackage intact and unused Disposable Falope-Ring® Band Applicators, subject them to a second sterilization process, and make them available for sale and distribution.
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