CraniSeal Dural Sealant
FDA PMAClass III (US FDA PMA)
by Pramand, LLC
Identity
- Trade Name
- CraniSeal Dural Sealant FDA PMA
- Generic Name
- Sealant, dural FDA PMA
Identifiers
- PMA Number
- P220014 FDA PMA
- FDA Product Code
- NQR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The CraniSeal Dural Sealant is a Class III medical device classified as a dural sealant. It is designed as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure of the dura mater in adult patients aged 18 years and older.
This device is supplied sterile and intended for single-use in surgical settings. It is approved under an FDA Premarket Approval (PMA) application (P220014) and is not indicated for MRI use. The product is distributed in various sizes and configurations, as referenced by its FEI numbers, and must be stored according to manufacturer instructions to maintain sterility and integrity.
Frequently asked questions
What is the CraniSeal Dural Sealant used for in surgical settings?
The CraniSeal Dural Sealant is designed as an adjunct to sutured dural repair during cranial surgery to help achieve a watertight closure of the dura mater in adult patients aged 18 and older. It is not intended as a standalone solution but works alongside sutures to improve sealing during procedures like craniotomies.
Is the CraniSeal Dural Sealant reusable or single-use, and how should it be stored?
The CraniSeal Dural Sealant is explicitly intended for **single-use** in sterile surgical settings. To maintain sterility and integrity, it must be stored according to the manufacturer’s instructions, which likely include keeping it in its original packaging until use.
What sizes or configurations are available for the CraniSeal Dural Sealant?
The device comes in multiple sizes and configurations, each identified by unique FEI numbers (e.g., 3035387162, 3016980830, etc.). These variations allow for flexibility in surgical applications, but the exact dimensions or intended use per size would require referencing the manufacturer’s documentation or product catalog.
Can the CraniSeal Dural Sealant be used in MRI procedures?
No, the CraniSeal Dural Sealant is **not approved for MRI use**. This limitation is explicitly stated in the device’s labeling, so it should not be used in patients who require MRI imaging.
How was the CraniSeal Dural Sealant approved by the FDA, and what does that mean for its use?
The CraniSeal Dural Sealant was approved via an FDA **Premarket Approval (PMA)** application (P220014), which is the highest level of regulatory review for Class III devices. This means the FDA has determined the device meets rigorous safety and effectiveness standards for its intended use as an adjunct to dural repair in cranial surgery for patients aged 18 and older.
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 | P220014 | Class III | Active |
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Manufacturer
- Manufacturer
- Pramand, LLC
Sources (1)
- FDA PMA P220014 24 fields · synced Sep 18, 2026