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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 SPECTRUM SALINE-FILLED MAMARY PROSTHESES
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namementor saline-filled breast implants
Regulation Number878.3530
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS007
Date Received03/26/2002
Decision Date04/23/2002
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of a supplier of silicone gel materials used in the lubrication of the spectrum valve channel in the mentor spectrum saline-filled breast implants. There will be no changes in any manufacturing processes.
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