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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.
 
DeviceDISPOSABLE FALOPE-RING BAND APPLICATOR KITS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS021
Date Received02/04/2016
Decision Date03/02/2016
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in supplier from Senior Operations LLC (formerly known as GA MFG Precision) to XL Precision for the manufacture of the Trocar Knife (Part No. 004556-503) and a manufacturing process change to produce a one-piece configuration Trocar Knife.
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