|
Device | IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | IDEALIMPLANT 14881 quorum drive suite 925 dallas, TX 75254 |
PMA Number | P120011 |
Supplement Number | S008 |
Date Received | 10/04/2016 |
Decision Date | 11/07/2016 |
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 device sampling plan for endotoxin testing. |