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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.
 
DeviceSaline-Filled and Spectrum Breast Implants
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS051
Date Received05/25/2021
Decision Date10/27/2021
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
Approval OrderApproval Order
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