|
Device | NATRELLE HIGHLY COHESIVE 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 | S016 |
Date Received | 05/24/2016 |
Decision Date | 08/17/2016 |
Product Code |
FTR |
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 changes to the presentation format of the indication-specific brochures and mini-brochure. |