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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 NameMENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP030053
Supplement NumberS026
Date Received03/19/2015
Decision Date04/15/2015
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to add an alternate supplier for isopropyl alcohol (ipa) used in the manufacture of mentor memorygel breast implants at mentor's irving, texas facility.
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