Definition: Reinforcement Of Soft Tissue Where Weakness Exists.
| Device Type ID | 5864 |
| Device Name | Collagen Surgical Mesh Containing Drugs |
| Physical State | An Acellular, Sterile, Non-pyrogenic Porcine Dermal Matrix . The Graft Is Packed Dry And Must Be Hydrated In Sterile Saline Prior To Use. The Thickness Of The Device Is 1.5 To 2.3mm. The Device Surfaces Are Coated With An Antimicrobial Coating, Which |
| Technical Method | Used To Reinforce Soft Tissue Defects, E.g., Hernias, Etc... |
| Target Area | Soft Tissues |
| Regulation Description | Surgical Mesh. |
| 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 | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5864 |
| Device | Collagen Surgical Mesh Containing Drugs |
| Product Code | PIJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Insufficient Information | 27 |
Defective Device | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Material Disintegration | 2 |
Appropriate Term/Code Not Available | 1 |
Shelf Life Exceeded | 1 |
Material Deformation | 1 |
Material Too Rigid Or Stiff | 1 |
| Total Device Problems | 38 |