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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.
 
DeviceIDEAL IMPLANT Structured Breast Implant
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
IDEALIMPLANT
14881 quorum drive suite 925
dallas, TX 75254
PMA NumberP120011
Supplement NumberS017
Date Received11/15/2019
Decision Date11/19/2020
Product Code FWM 
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 for a change in the procedures used to manage Out-of-Specification (OOS) mechanical testing measurements.
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