|
Device | MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES |
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 | S012 |
Date Received | 07/16/2003 |
Decision Date | 08/15/2003 |
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
CHANGE IN THE SUPPLIER FOR THE SILICONE ELASTOMER FILL TUBE. |