|
Device | MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant |
MENTOR WORLDWIDE LLC |
33 technology drive |
irvine, CA 92618 |
|
PMA Number | P990075 |
Supplement Number | S033 |
Date Received | 06/10/2015 |
Decision Date | 07/01/2015 |
Product Code |
FWM
|
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. |