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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 BAND 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 NumberS010
Date Received05/04/2010
Decision Date06/02/2010
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the supplier of three components.
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