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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, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
PMA NumberP990074
Supplement NumberS026
Date Received05/20/2013
Decision Date06/12/2013
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 
Allergan costa rica facility add manufacturing space (floor space) to its production area in the shell soaking and scrubbing room (room 2) and gowning room (room 3) and new hepa filters to room 2.