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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.
 
DeviceFALOPE-RING CAND AND APPLICATOR SYSTEMS
Classification Namedevice, occlusion, tubal, contraceptive, laparoscopic
Generic Namedevice, occlusion, tubal, contraceptive, laparoscopic
Regulation Number884.5380
Applicant
Gyrus ACMI, Inc.
136 turnpike rd.
southborough, MA 01772
PMA NumberP870076
Supplement NumberS013
Date Received10/04/2012
Decision Date10/26/2012
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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