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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 | S022 |
Date Received | 09/30/2019 |
Decision Date | 10/29/2019 |
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 Variable Frequency Drive (VFD) to the Dipping Hood blower system used in the manufacturing of Sientra OPUS® Silicone Gel Breast Implants. |