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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.
 
DeviceTrocar Knife
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus ACMI, Inc.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772
PMA NumberP870076
Supplement NumberS024
Date Received01/13/2020
Decision Date02/12/2020
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  
Qualification of a new supplier of the Trocar Knife (part number 004556-503) to assure that it will continue to meet the previously approved specifications for this component. The Trocar Knife is currently supplied by XL Precision and was proposed to be supplied by the new supplier RMS Surgical.
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