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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.
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
PMA NumberP060028
Supplement NumberS015
Date Received10/22/2015
Decision Date11/20/2015
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.