PMA P060028S011

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S011
Product code: FTR
Decision date: 2015-05-08
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: CHANGE TO USE SEGREGATION BASKETS FOR IN-PROCESS SHELL COMPONENT IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.

Current openFDA PMA Record#

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S011
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2015-05-08
Decision code: OK30
Date received: 2015-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO USE SEGREGATION BASKETS FOR IN-PROCESS SHELL COMPONENT IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.