Motiva® Inflatable Balloon - Motiva® Inflatable Balloon - 8 cm base
2025-06-06
ESTABLISHMENT LABS S.A.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012883202 | 3012883202 | ESTABLISHMENT LABS S.A. | 1 | N | 2026-01-01 | Coyol Free Zone & Business Park Building 4th Street, Building B-15 Coyol Alajuela CR 20113 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 234590 | 1685335458 | P230005 | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas | FTR | 2024-09-26 |
| 234590 | 1435177977 | K211676 | Motiva Flora SmoothSilk Tissue Expander | LCJ | 2023-10-13 |
| 234590 | 1963847181 | K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | MRD | 2019-02-05 |
| 234590 | 1195633226 |
Product Codes Associated With Registrations#
GUDID#
Motiva® Inflatable Balloon - Motiva® Inflatable Balloon - 9 cm base
2025-06-06
Motiva® Inflatable Balloon - Motiva® Inflatable Balloon - 10 cm base
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