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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 BAND & APPLICATOR SYSTEMS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus ACMI, Inc.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772
PMA NumberP870076
Supplement NumberS011
Date Received06/15/2010
Decision Date07/08/2010
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN SUPPLIER OF THREE COMPONENTS OF THE DEVICE.
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