Device |
dressing, wound and burn, interactive |
Review Panel |
General & Plastic Surgery |
Product Code | MGR |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|