| Device Type ID | 5725 |
| Device Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| 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 | LMG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5725 |
| Device | Agent, Absorbable Hemostatic, Non-collagen Based |
| Product Code | LMG |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Absorbable Hemostatic Agent And Dressing. |
| CFR Regulation Number | 878.4490 [🔎] |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 26 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Break | 14 |
Degraded | 13 |
Product Quality Problem | 6 |
Torn Material | 6 |
Insufficient Information | 6 |
Device Markings / Labelling Problem | 4 |
Patient Device Interaction Problem | 4 |
Difficult To Insert | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Component Incompatible | 2 |
Use Of Device Problem | 2 |
Loss Of Or Failure To Bond | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Unsealed Device Packaging | 1 |
Detachment Of Device Component | 1 |
Shelf Life Exceeded | 1 |
Noise, Audible | 1 |
| Total Device Problems | 110 |