| Device |
aortic heart valve, more than minimally manipulated allograft |
| Definition |
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients. |
| Physical State |
More than minimally manipulated aortic allograft heart valve |
| Technical Method |
Surgical replacement |
| Target Area |
Aortic valve |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PAP |
|---|
| Submission Type |
HDE
|
|---|
| Device Class |
3 (De Novo Petitions Granted)
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
