FDA.reportPublic FDA data

PMA P030053S079

Device
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S079
Product code
FTR
Decision date
2025-05-21
Classification
General, Plastic Surgery
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
for implementation of new mold release spray to be used on the rubber processing mill for silicone elastomers used in the manufacturing of MemoryGel™ (P030053), MemoryShape™ (P060028) and Saline-Filled/SPECTRUM™ Breast Implants.

Current openFDA PMA Record#

Device
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S079
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2025-05-21
Decision code
OK30
Date received
2025-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
for implementation of new mold release spray to be used on the rubber processing mill for silicone elastomers used in the manufacturing of MemoryGel™ (P030053), MemoryShape™ (P060028) and Saline-Filled/SPECTRUM™ Breast Implants.