Identity
- Trade Name
- INTEGRA DERMAL REGENERATION TEMPLATE FDA PMA
- Generic Name
- Dressing, wound and burn, interactive FDA PMA
Identifiers
- PMA Number
- P900033 FDA PMA
- FDA Product Code
- MGR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Integra Dermal Regeneration Template is an interactive dressing for wound and burn management, classified under the generic name Dressing, wound and burn, interactive. It is designed to support dermal regeneration in clinical settings.
Supplied by Integra Lifesciences Corp., this device holds FDA PMA approval (P900033) and is categorized under product code MGR. It is intended for use in general and plastic surgery applications as indicated by its advisory committee classification.
Frequently asked questions
What is the generic name of the Integra Dermal Regeneration Template?
The generic name of the Integra Dermal Regeneration Template is Dressing, wound and burn, interactive, as specified in the device data under the openfda field.
What regulatory authorization does the Integra Dermal Regeneration Template have?
The Integra Dermal Regeneration Template has FDA PMA approval, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P900033 in the specifications.
Who manufactures the Integra Dermal Regeneration Template?
The Integra Dermal Regeneration Template is manufactured by Integra Lifesciences Corp., as stated in both the MANUFACTURER field and the applicant and openfda fields.
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. Sources consulted: Integra LifeSciences
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P900033 | Class III | Active |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA PMA P900033 24 fields · synced Sep 18, 2026