Collacote Absorbable Collagen Wound Dressing
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- COLLACOTE(TM) FDA PMA
- Generic Name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID FDA PMA
Identifiers
- PMA Number
- P840062 FDA PMA
- FDA Product Code
- LPG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Collacote, Collatape, and Collalug absorbable collagen wound dressing is a surgical dressing material designed for clinical application. It functions as a wound dressing to support the management of surgical sites.
This device is manufactured by Integra Lifesciences Corp. and has received FDA PMA authorization. It is categorized as a surgical dressing material for use in professional medical settings.
Frequently asked questions
What is the primary function of the Collacote, Collatape, and Collalug dressing?
This device is a surgical dressing material intended to be used as a wound dressing in clinical or surgical environments.
Who is the manufacturer of this wound dressing?
The Collacote, Collatape, and Collalug absorbable collagen wound dressing is manufactured by Integra Lifesciences Corp., based in Plainsboro, New Jersey.
Is this device authorized for use?
Yes, the device has received FDA PMA authorization, which indicates it has undergone the premarket approval process required for class III medical devices.
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: CollaPlug® and CollaTape® Overview - Dental Implant - Scribd, Establishment Registration & Device Listing - FDA, [PDF] 1998 Annual Report - Integra LifeSciences, EFFECT OF COLLAPLUG® ON THE HEALING OF ..., [PDF] Cardiovascular Effects and Efficacy of a Hemostatic Agent in ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P840062 | Class III | Active |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA PMA P840062 24 fields · synced Sep 18, 2026