PMA P060028S008

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S008
Product code: FTR
Decision date: 2015-03-19
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: CHANGES IN THE PRODUCTION OF MEMORYSHAPE BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. THE CHANGES INCLUDE EXPANDING THE GOWNING AREA, INCREASING THE NUMBER OF DRYING RODS IN THE SHELL DRYING OVEN AND UPDATING THE BOWL FILL PROCEDURE.

Current openFDA PMA Record#

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S008
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2015-03-19
Decision code: OK30
Date received: 2015-02-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES IN THE PRODUCTION OF MEMORYSHAPE BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. THE CHANGES INCLUDE EXPANDING THE GOWNING AREA, INCREASING THE NUMBER OF DRYING RODS IN THE SHELL DRYING OVEN AND UPDATING THE BOWL FILL PROCEDURE.