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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 MAMMARY PROSTHESES
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namementor saline-filled breast implants
Regulation Number878.3530
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS005
Date Received07/09/2001
Decision Date10/31/2001
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised patient labeling that incorporates the results of the focus group study.
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