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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
Generic Namementor saline-filled breast implants
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS006
Date Received07/26/2001
Decision Date08/09/2001
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for lal testing to be done on a skip lot audit basis every six months.
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