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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.
 
DeviceMENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMENTOR CORP.
33 TECHNOLOGY DRIVE
IRVINE, CA 92618
PMA NumberP030053
Supplement NumberS004
Date Received03/27/2007
Decision Date04/27/2007
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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