|
Device | NATRELLE SALINE-FILLED BREAST IMPLANTS |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S030 |
Date Received | 08/06/2014 |
Decision Date | 11/04/2014 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MATERIAL FOR ONE COMPONENT USED IN THE FILL TUBE FOR NATRELLE SALINE-FILLED BREAST IMPLANTS. |