|
Device | MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS |
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 | S025 |
Date Received | 01/22/2014 |
Decision Date | 02/20/2014 |
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 ADD AN ADDITIONAL SUPPLIER FOR COMPONENTS USED IN THE MANUFACTURE OF MENTOR¿S SALINE-FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS. |