FDA device listing
Natrelle 133 Plus Tissue Expander,Natrelle 133 Plus Tissue Expander - 133P FV, 133P FX, 133P MV, 133P MX, 133P SX, 133P…
FDA device listing 1648111475 · AbbVie, Inc.
Key facts
| Proprietary names | Natrelle 133 Plus Tissue Expander,Natrelle 133 Plus Tissue Expander - 133P FV, 133P FX, 133P MV, 133P MX, 133P SX, 133P SV, 133P LV |
|---|---|
| Owner/operator | AbbVie, Inc. |
| Owner/operator number | 2011068 |
| Premarket submissions | K143354 |
| Product codes | LCJ |
| Device names | LCJ - Tissue Expander And Accessories |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LCJ |
| Review panels | General & Plastic Surgery |
| Registered establishments | ALLERGAN, ALLERGAN SALES, LLC |
| Establishment registrations | 2011068, 9617229 |
| FEI numbers | 2011068, 3006108784 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database