SpineSeal Spine Sealant
FDA PMAClass III (US FDA PMA)
by Pramand, LLC
Identity
- Trade Name
- SpineSeal Spine Sealant FDA PMA
- Generic Name
- Sealant, dural FDA PMA
Identifiers
- PMA Number
- P240027 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 SpineSeal Spine Sealant is a dural sealant indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure. This device is designed to help ensure proper sealing of the dura mater in spinal surgical procedures.
The SpineSeal Spine Sealant is manufactured by Pramand, LLC and has received FDA PMA approval. It is supplied as a single-use device and is intended for use in spinal surgery settings. The device is classified under product code NQR and is authorized for use as an adjunct to sutured dural repair to achieve watertight closure.
Frequently asked questions
What is the primary indication for the SpineSeal Spine Sealant?
The SpineSeal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure. It is not intended as a replacement for sutures but rather as a complementary product to enhance the sealing of the dura mater.
Is the SpineSeal Spine Sealant reusable or single-use?
The SpineSeal Spine Sealant is supplied as a single-use device. It should not be reused or resterilized for patient safety and regulatory compliance reasons. Each unit is intended for one surgical procedure only.
What regulatory approvals does the SpineSeal Spine Sealant have?
The SpineSeal Spine Sealant has received FDA PMA (Pre-market Approval) with the approval number P240027. This indicates that the device has undergone rigorous review by the FDA and is deemed safe and effective for its intended use as an adjunct to sutured dural repair during spinal surgery.
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 | P240027 | Class III | Active |
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Manufacturer
- Manufacturer
- Pramand, LLC
Sources (1)
- FDA PMA P240027 24 fields · synced Sep 18, 2026