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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 CORP.
PMA NumberP030053
Supplement NumberS004
Date Received03/27/2007
Decision Date04/27/2007
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the post-approval study to allow for the voluntary rather than mandatory participation of all patients, irrespective of the type of implant (i. E. , memorygel implant or saline implants) they receive.
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