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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 | S034 |
Date Received | 01/31/2022 |
Decision Date | 03/02/2022 |
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 Addition of a gel dispersion viscosity assessment method, ‘Percent Solids Method’ to provide supplementary dispersion viscosity information during the manufacture of Sientra Silicone Gel Breast Implants. |