Chrysalis Intelligence · Sponsors · Motiva USA, LLC

Motiva USA, LLC

Santa Barbara, CA, US · 1 510(k) clearances · 4 PMAs

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
1
2023-10-13 → 2023-10-13
Last 12 months
0
Product codes
1
Most recent
2023-10-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LCJ Tissue Expander And Accessories Unclassified Unknown 1 2023-10-13
Class III

PMA approvals (4)

Total PMA records
4
Originals + supplements
Distinct product codes
1
First decision
2024-09-26
Most recent
2026-09-25
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-25 P230005-S005 Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants 135 Review Track For 30-Day Notice FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery
2025-12-17 P230005-S003 Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants 30-Day Notice FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery
2024-11-22 P230005-S001 Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas Normal 180 Day Track No User Fee FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery
2024-09-26 P230005 Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas Original FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2023-10-13 K211676 Motiva Flora SmoothSilk Tissue Expander LCJ Unclassified Unknown
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence