Identity
- Trade Name
- HEMOBLAST Bellows FDA PMA
- Generic Name
- Absorbable collagen hemostatic agent with thrombin FDA PMA
Identifiers
- PMA Number
- P170012 FDA PMA
- FDA Product Code
- PMX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 878.4490 FDA PMA
- Regulation Number
- 878.4490 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Hemoblast Bellows is an absorbable collagen hemostatic agent with thrombin, classified as a Class III device. It is designed to assist in achieving hemostasis during surgical procedures when conventional methods are ineffective or impractical, excluding neurosurgical, ophthalmic, and urological applications.
This device is supplied as a sterile, single-use adjunct for surgical hemostasis and is regulated under FDA Premarket Approval (PMA P170012). It is intended for use in general and plastic surgery settings, adhering to regulatory standards outlined in 21 CFR 878.4490. The device is packaged and stored under conditions ensuring sterility and integrity prior to use.
Frequently asked questions
What types of surgical procedures is the Hemoblast Bellows intended for, and where should it not be used?
The Hemoblast Bellows is designed as an adjunct for achieving hemostasis during general and plastic surgery procedures when conventional methods fail or are impractical. It is **not** intended for neurosurgical, ophthalmic, or urological applications, as explicitly excluded in its regulatory description.
Is the Hemoblast Bellows reusable, or is it meant for single-use only?
The Hemoblast Bellows is supplied as a **sterile, single-use** device. It is packaged and stored under conditions ensuring sterility and integrity prior to use, which aligns with standard practices for absorbable hemostatic agents to prevent contamination and maintain efficacy.
How should the Hemoblast Bellows be stored before use, and what guarantees its sterility?
The device is packaged and stored under conditions that preserve **sterility and integrity** before use. The manufacturer ensures this through controlled storage environments, as outlined in the regulatory submission, which is critical for maintaining its effectiveness as a single-use hemostatic agent.
What regulatory pathway was followed for the approval of the Hemoblast Bellows, and what does that mean for its use?
The Hemoblast Bellows was approved through the **FDA Premarket Approval (PMA) pathway** under PMA number P170012. This means it underwent rigorous review by the FDA to ensure safety and effectiveness as an absorbable collagen hemostatic agent with thrombin, adhering to the regulatory standards of 21 CFR 878.4490 for Class III 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170012 | Class III | Active |
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Manufacturer
- Manufacturer
- Dilon Technologies, Inc.
Sources (1)
- FDA PMA P170012 24 fields · synced Sep 18, 2026