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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
ApplicantIDEALIMPLANT
14881 quorum drive suite 925
dallas, TX 75254
PMA NumberP120011
Supplement NumberS018
Date Received03/17/2020
Decision Date04/03/2020
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add 100% visual inspection and manual flash removal from the valve seat after cryogenic deflashing.
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