Definition: Approximation Of Tissue Layers Where Subcutaneous Dead Space Exists Between The Tissue Planes In Abdominoplasty.
| Device Type ID | 5865 |
| Device Name | Tissue Adhesive For Internal Use |
| Physical State | A Surgical Adhesive Based On A Polyurethane Pre-polymer. In Its Pre-polymerized Form, This Is A Viscous Liquid. The Primary Component Of The Adhesive Is Created By Reacting Trimethylolpropane (TMP) With Lysine Di-isocyanate Ethyl Ester (LDI). |
| Technical Method | The Liquid Is Applied Drop-wise To The Tissue Surfaces To Be Adhered, And Then The Tissue Surfaces Are Approximated For Several Minutes To Allow The Moisture In The Tissue To Initiate The Curing Process. The Applicator Is A Hand-held, Disposable Devi |
| Target Area | Abdominoplasty Tissue Flaps |
| Regulation Description | Tissue Adhesive. |
| 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 | 878.4010 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PJK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5865 |
| Device | Tissue Adhesive For Internal Use |
| Product Code | PJK |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Tissue Adhesive. |
| CFR Regulation Number | 878.4010 [🔎] |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 7 |
Packaging Problem | 6 |
Tear, Rip Or Hole In Device Packaging | 3 |
| Total Device Problems | 16 |