Definition: Intended For Use As An Adjunct To Hemostasis When Control Of Bleeding By Ligature Or Conventional Procedures Is Ineffective Or Impractical.
| Device Type ID | 5871 |
| Device Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Physical State | Collagen Plus Thrombin |
| Technical Method | Hemostatic Agent Combining Tamponade And Acceleration Of Fibrin Clot Formation |
| Target Area | Surgical Procedures Other Than Ophthalmic |
| Regulation Description | Absorbable Hemostatic Agent And Dressing. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | PMA |
| CFR Regulation Number | 878.4490 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PMX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5871 |
| Device | Absorbable Collagen Hemostatic Agent With Thrombin |
| Product Code | PMX |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Absorbable Hemostatic Agent And Dressing. |
| CFR Regulation Number | 878.4490 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corporation | II | Aug-30-2018 |