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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNATRELLE Silicon-Filled Breast Implants
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP020056
Supplement NumberS046
Date Received12/18/2017
Decision Date06/27/2018
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement an additional incoming specification, i.e., verify the color of the gel material by using the Ultra Scan VIS Sensor System to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 Parkway Global Park, La Aurora, Heredia, Costa Rica manufacturing site.
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