| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas |
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| Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
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| Regulation Number | 878.3540 |
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| Applicant | Motiva, USA, LLC
2543 Mesa School Lane
Santa Barbara, CA 93109 |
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| PMA Number | P230005 |
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| Date Received | 02/24/2023 |
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| Decision Date | 09/26/2024 |
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| Product Code |
FTR |
| Docket Number | 24M-4559 |
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| Notice Date | 11/24/2024 |
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| Advisory Committee |
General & Plastic Surgery |
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| Clinical Trials | NCT03579901
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
The Motiva SmoothSilk Round and SmoothSilk Round Ergonomix breast implants are indicated for breast augmentation for women of at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S003 |
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