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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namementor saline-filled breast implants
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP990075
Supplement NumberS025
Date Received01/22/2014
Decision Date02/20/2014
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an additional supplier for components used in the manufacture of mentor¿s saline-filled breast implants and spectrum breast implants.
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