Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4490](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4490) → PMX — Absorbable Collagen Hemostatic Agent With Thrombin

# PMX · Absorbable Collagen Hemostatic Agent With Thrombin

_General, Plastic Surgery · 21 CFR 878.4490 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX

## Overview

- **Product Code:** PMX
- **Device Name:** Absorbable Collagen Hemostatic Agent With Thrombin
- **Regulation:** [21 CFR 878.4490](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4490)
- **Device Class:** 3
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

## Classification Rationale

Class III.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P170012](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX/P170012.md) | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | Dec 15, 2017 | APPR |
| [P050044](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX/P050044.md) | VITAGEL RT3 SUTGICAL HEMOSTAT | Stryker Corp. | Jun 16, 2006 | APWD |
| [P990030](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX/P990030.md) | VITAGEL SURGICAL HEMOSTAT | Angiotech Medical Device Technologies | Jun 13, 2000 | APWD |
| [P990009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX/P990009.md) | FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT | Baxter Healthcare Corp | Dec 8, 1999 | APPR |

## Top Applicants

- Angiotech Medical Device Technologies — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Dilon Technologies, Inc. — 1 clearance
- Stryker Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMX)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com