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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFALOPE RING BAND AND APPLICATOR SYSTEMS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Date Received12/07/1987
Decision Date09/29/1993
Product Code KNH 
Docket Number 93M-0381
Notice Date 11/10/1993
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S005 S006 S003 S004 S001  S009 S017 S016 S007 S008 S019 
S020 S023 S012 S018 S013 S014 S015 S010 S011 S021 S022 S024 
S025 S026 S027 
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