|
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 | S032 |
Date Received | 09/29/2014 |
Decision Date | 10/29/2014 |
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 CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING. |