Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
• Classification Name: prosthesis, breast, noninflatable, internal, silicone gel-filled
• Regulation Number: 878.3540
• Applicant: MENTOR CORP.
• PMA Number: P030053
• Date Received: 12/12/2003
• Decision Date: 11/17/2006
• Product Code: FTR [ Registered Establishments with FTR ]
• Docket Number: 06M-0492
• Notice Date: 11/17/2006
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Information About: Labeling, Approval Order, Summary of Safety and Effectiveness

Approval Order Statement 
Approval for the mentor memorygel silicone gel-filled breast implants. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Approval Order

Approval Order

Post-Approval Study

Show Report Schedule and Study Progress

• Supplements: S001 S002 S004 S005 S006 S008 ; S009 S011 S012