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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
Applicant
MENTOR 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 - ode/oir
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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