|
Device | NATRELLE Highly Cohesive Anatomically Shaped 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 | S021 |
Date Received | 03/01/2017 |
Decision Date | 08/28/2017 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10%; (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). |