| Device |
tissue adhesive for internal use |
| Regulation Description |
Tissue adhesive. |
| Definition |
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. |
| 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 device that stores 5 ml of adhesive for delivery in drops onto planar surfaces of tissue. When exposure to water, the product reacts with amine and hydroxyl groups on biological tissue and with itself to produce a polymerized network. |
| Target Area |
Abdominoplasty tissue flaps |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PJK |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
PMA
|
|---|
| Regulation Number |
878.4010
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
