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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 NameSALINE FILLED BREAST IMPLANT
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
PMA NumberP990074
Supplement NumberS003
Date Received11/29/2000
Decision Date12/15/2000
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the product lal testing from a release test for every sterilization lot, to a manufacturing change control tool used for process and material changes. There will be no adverse effect to the device as a result of changing the lal testing from a release test to a qualification test. Historical records of lal testing on finished product demonstrate the product manufacturing process is controlled and predictable, delivering an endotoxin-free product.
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