Natrelle Saline-Filled Breast Implants
FDA PMAFDA UDIClass III (US FDA PMA)
by Allergan
Identity
- Trade Name
- NATRELLE SALINE BREAST IMPLANTS FDA PMANATRELLE Saline-Filled Breast Implants FDA UDI
- Generic Name
- Prosthesis, breast, inflatable, internal, saline FDA PMASaline-filled breast implant, unstructured, textured-surface FDA UDI
- Device Name
- NATRELLE 468-230 Moderate Projection BIOCELL |textured|contour|saline FDA UDI
- Model / Reference
- 468-230 FDA UDI
- Description
- NATRELLE 468-230 Moderate Projection BIOCELL |textured|contour|saline FDA UDI
Identifiers
- Catalog Number
- 468-230 FDA UDI
- Primary DI / UDI-DI
- 10888628001091 FDA UDI
- PMA Number
- FDA Product Code
- FWM FDA PMAFDA UDI
- GMDN Term
- Saline-filled breast implant, unstructured, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA PMAFDA UDI
- Legislation / Framework
- 21 CFR Part 878.3530 FDA PMA
- Regulation Number
- 878.3530 FDA PMAFDA UDI
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
The Natrelle Saline-Filled Breast Implants are classified as Prosthesis, Breast, Inflatable, Internal, Saline, a device designed for breast augmentation or reconstruction. These implants are filled with sterile saline solution and feature a cohesive gel shell to maintain shape and stability within the breast tissue. They are intended for use in elective cosmetic procedures or post-mastectomy reconstruction under sterile surgical conditions.
These implants are supplied as single-use, sterile devices and are regulated under FDA PMA approval (P990074). They are available in various sizes and shell thicknesses, as indicated by the assigned product codes and registration numbers. Storage and handling must comply with sterile surgical protocols, and compatibility with MRI is not specified in the regulatory data. The devices are intended for use in Class III procedures, adhering to strict manufacturing and quality control standards.
Frequently asked questions
Are Natrelle saline-filled breast implants reusable or intended for single-use only?
Natrelle saline-filled breast implants are **strictly single-use devices**. This classification aligns with FDA PMA requirements for saline-filled breast prostheses, ensuring patient safety by preventing contamination or degradation from repeated use. Each implant is sterile upon packaging and must not be reused after initial surgical implantation.
What storage conditions are required for Natrelle saline-filled breast implants before surgery?
Natrelle saline-filled breast implants must be stored according to **sterile surgical protocols** to maintain integrity. They are supplied in sterile packaging, so they should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures. The cohesive gel shell and saline fill require protection from physical damage or contamination prior to implantation.
How do I determine the size or shell thickness of a Natrelle saline-filled breast implant?
The size and shell thickness of Natrelle saline-filled breast implants are identified by their **product codes and registration numbers** (e.g., 1645337, 3010531069). These identifiers correspond to specific dimensions and shell thicknesses listed in the regulatory data (e.g., FEI numbers like 2011068 or 3006165545). Referencing the manufacturer’s documentation or catalog will clarify the exact measurements for each variant.
What is the intended clinical use for Natrelle saline-filled breast implants, and how are they different from other saline implants?
Natrelle saline-filled breast implants are **intended for breast augmentation or post-mastectomy reconstruction** under sterile surgical conditions, as classified under the generic name *Prosthesis, Breast, Inflatable, Internal, Saline*. Unlike other saline implants, they feature a **cohesive gel shell** designed to maintain shape and stability within breast tissue, which helps reduce the risk of wrinkling or displacement. They are regulated under FDA PMA approval (P990074) for Class III procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990074 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan
Sources (2)
- FDA PMA P990074 24 fields · synced Sep 18, 2026
- FDA UDI f393e95a-44de-44f1-9bfe-3f786dadb6da 38 fields · synced May 27, 2026