|
Device | Sientra OPUS Silicone Gel Breast Implants |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | SIENTRA, INC 6769 HOLLISTER AVENUE SUITE 201 SANTA BARBARA, CA 93117 |
PMA Number | P070004 |
Supplement Number | S033 |
Date Received | 08/06/2021 |
Decision Date | 10/27/2021 |
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 patient and physician labeling including a boxed warning and a patient decision checklist. |
Approval Order | Approval Order |