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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 NameHIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000
Generic Namesaline-filled mammary prosthesis
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS003
Date Received05/14/2001
Decision Date06/18/2001
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the high profile round saline-filled breast implant, style 3000.
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