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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 AND APPLICATOR SYSTEMS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS014
Date Received10/20/2014
Decision Date11/17/2014
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 LABELING CLARIFICATIONS REGARDING NOT LOADING DEVICES MORE THAN THIRTY MINUTES BEFORE USE, AND REDUCING LANGUAGES IN DEVICE LABELING TO ONLY ENGLISH AND FRENCH.
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