PMX · Absorbable Collagen Hemostatic Agent With Thrombin
General, Plastic Surgery · 21 CFR 878.4490 · Class 3
Overview
| Product Code | PMX |
|---|---|
| Device Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Regulation | 21 CFR 878.4490 |
| Device Class | Class 3 |
| Review Panel | General, Plastic Surgery |
| 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 | HEMOBLAST Bellows | Dilon Technologies, Inc. | Dec 15, 2017 | APPR |
| P050044 | VITAGEL RT3 SUTGICAL HEMOSTAT | Stryker Corp. | Jun 16, 2006 | APWD |
| P990030 | VITAGEL SURGICAL HEMOSTAT | Angiotech Medical Device Technologies | Jun 13, 2000 | APWD |
| P990009 | 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
