|
Device | NATRELLE HIGHLY COHESIVE ANATOMICALLY SILICONE-FILLED BREAST IMPLANTS |
Generic Name | prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P040046 |
Supplement Number | S018 |
Date Received | 11/07/2016 |
Decision Date | 12/07/2016 |
Product Code |
FTR |
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 method for bioburden monitoring. |