PMA P060028S014

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S014
Product code: FTR
Decision date: 2016-02-05
Classification: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval for 1) change 100291296: Update packaging processes with Alloyd Heat Sealers and Tyvek Pouch to implement the use of the Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices; and 2) change 100248737: minor layout modifications to the gel fill area were made to increase operational efficiency.

Current openFDA PMA Record#

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S014
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2016-02-05
Decision code: APPR
Date received: 2015-09-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for 1) change 100291296: Update packaging processes with Alloyd Heat Sealers and Tyvek Pouch to implement the use of the Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices; and 2) change 100248737: minor layout modifications to the gel fill area were made to increase operational efficiency.