FDA.reportPublic FDA data

PMA P030053S089

Device
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S089
Product code
FTR
Decision date
2026-05-01
Classification
General, Plastic Surgery
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
The updated Mentor’s oven recipe to cure the device now match the manufacturer, Nusil, and results do not appear to make a significant change in the product.

Current openFDA PMA Record#

Device
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S089
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2026-05-01
Decision code
OK30
Date received
2026-04-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
The updated Mentor’s oven recipe to cure the device now match the manufacturer, Nusil, and results do not appear to make a significant change in the product.