Zyderm Collagen Implant (Zyderm CI)
FDA PMAClass III (US FDA PMA)
by Allergan
Identity
- Trade Name
- ZYDERM COLLAGEN IMPLANT (ZYDERM CI) FDA PMA
- Generic Name
- Implant, dermal, for aesthetic use FDA PMA
Identifiers
- PMA Number
- P800022 FDA PMA
- FDA Product Code
- LMH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S005 FDA PMA
The Zyderm Collagen Implant (Zyderm CI) is a dermal implant classified as an Implant, Dermal, for Aesthetic Use, designed for soft tissue augmentation. It is composed of bovine-derived collagen, intended to restore volume and contour to facial areas affected by aging or trauma. This device is intended for subcutaneous or intradermal placement to improve skin texture and reduce the appearance of wrinkles.
The Zyderm CI is supplied as a sterile, single-use product and is administered by a healthcare professional in an outpatient or clinical setting. It requires refrigeration prior to use and must be handled with sterile techniques. Approved under an FDA Premarket Approval (PMA), this device adheres to strict regulatory standards for dermal implants. Multiple registration numbers and product codes (e.g., LMH, P800022) identify its authorized variants and compliance status.
Frequently asked questions
What types of facial areas can the Zyderm Collagen Implant be used to improve, and how is it administered?
The Zyderm Collagen Implant is designed for soft tissue augmentation in facial areas affected by aging or trauma, such as reducing wrinkles or restoring volume. It is administered by a healthcare professional through subcutaneous (under the skin) or intradermal (within the skin) placement. The procedure is typically performed in an outpatient or clinical setting, requiring sterile techniques during administration.
Is the Zyderm Collagen Implant intended for reuse, and what storage conditions are required before use?
The Zyderm Collagen Implant is a single-use product, meaning it is not intended for reuse after one administration. Before use, it must be stored under refrigeration to maintain its sterility and efficacy. Always handle it with sterile techniques to prevent contamination.
What regulatory pathway was followed for the approval of the Zyderm Collagen Implant, and what does this mean for its use?
The Zyderm Collagen Implant was approved through the FDA’s Premarket Approval (PMA) process, which is the strictest regulatory pathway for Class III medical devices. This approval ensures the device meets rigorous safety and effectiveness standards for dermal implants intended for aesthetic use, such as soft tissue augmentation and wrinkle reduction.
Are there multiple variants or sizes of the Zyderm Collagen Implant, and how can I verify its regulatory compliance?
Yes, the Zyderm Collagen Implant comes in multiple variants, each identified by unique registration numbers (e.g., 1000118068, 3007093114) and product codes (e.g., LMH). To verify its regulatory compliance, check the registration numbers or product codes listed on the packaging against the FDA’s OpenFDA database or the manufacturer’s documentation, as these confirm its authorized status under the PMA pathway.
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 | P800022 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan
Sources (1)
- FDA PMA P800022 24 fields · synced Sep 18, 2026