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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.
 
DeviceADIANA PERMANENT CONTRACEPTION SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP070022
Supplement NumberS014
Date Received02/28/2011
Decision Date09/06/2011
Withdrawal Date10/23/2012
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR CHANGES TO THE SUGAR MOLD MANUFACTURING PROCESS.
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