FDA.reportPublic FDA data

PMA P030053S056

Device
MemoryGel Xtra Silicone Gel-Filled Breast Implant
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S056
Product code
FTR
Decision date
2020-12-21
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
Approval of the Smooth Moderate High Profile Xtra Silicone Gel-filled Breast Implants, which is an extension to the MemoryGel Xtra Breast Implants product line.

Current openFDA PMA Record#

Device
MemoryGel Xtra Silicone Gel-Filled Breast Implant
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S056
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2020-12-21
Decision code
APPR
Date received
2020-09-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of the Smooth Moderate High Profile Xtra Silicone Gel-filled Breast Implants, which is an extension to the MemoryGel Xtra Breast Implants product line.