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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFALOPE-RING BAND AND APPLICATOR SYSTEMS
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion device
Regulation Number884.5380
ApplicantGYRUS ACMI, INC.
PMA NumberP870076
Supplement NumberS014
Date Received10/20/2014
Decision Date11/17/2014
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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