| Device Type ID | 5724 |
| Device Name | Agent, Absorbable Hemostatic, 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 | LMF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5724 |
| Device | Agent, Absorbable Hemostatic, Collagen Based |
| Product Code | LMF |
| 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 | 118 |
Device Contamination With Chemical Or Other Material | 55 |
Adverse Event Without Identified Device Or Use Problem | 52 |
Device Operates Differently Than Expected | 7 |
Crack | 6 |
Break | 5 |
Insufficient Information | 5 |
Device Markings / Labelling Problem | 5 |
Plug | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Material Integrity Problem | 3 |
Cannula | 3 |
Housing | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Device Or Component Shipped | 2 |
Component Incompatible | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Cap | 2 |
Patient-Device Incompatibility | 1 |
Syringe | 1 |
Delivered As Unsterile Product | 1 |
Particulates | 1 |
Tidal Volume Fluctuations | 1 |
Use Of Device Problem | 1 |
Material Fragmentation | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
No Pressure | 1 |
Dent In Material | 1 |
| Total Device Problems | 293 |