Device |
absorbable collagen hemostatic agent with thrombin |
Regulation Description |
Absorbable hemostatic agent and dressing. |
Definition |
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
Physical State |
collagen plus thrombin |
Technical Method |
Hemostatic agent combining tamponade and acceleration of fibrin clot formation |
Target Area |
Surgical procedures other than ophthalmic |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | PMX |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
PMA
|
Regulation Number |
878.4490
|
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 |