DevicePMAs@therightstef:P060028_S000 JSONTXT 13 Projects

Approval for thememoryshape breast implants. this device is indicated for females for the following uses(procedures):1) breast augmentation for women at least 22 years old. breast augmentation includes primarybreast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. 2) breast reconstruction. breast reconstruction includes primary reconstruction to replacebreast 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 revisionsurgery to correct or improve the results of a primary breast reconstruction surgery.