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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 CAND AND APPLICATOR SYSTEMS
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion device
Regulation Number884.5380
ApplicantGYRUS ACMI, INC.
PMA NumberP870076
Supplement NumberS013
Date Received10/04/2012
Decision Date10/26/2012
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 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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