|
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 | S003 |
Date Received | 03/28/2016 |
Decision Date | 11/17/2016 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted |