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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 CAND AND APPLICATOR SYSTEMS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS013
Date Received10/04/2012
Decision Date10/26/2012
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 CHANGES INCLUDING ADDING/ MODIFYING WARNINGS IN THE INSTRUCTION FOR USE, UPDATING COMPANY BRANDING, AND SEPARATING THE QUICK REFERENCE GUIDES FOR THE REUSABLE AND DISPOSABLE APPLICATORS.
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