Device Type ID | 1019 |
Device Name | Tissue Graft Of Less Than 6mm |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
Submission Type | Contact ODE |
FDA Device Classification | Class 3 Medical Device |
Product Code | LWZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1019 |
Device | Tissue Graft Of Less Than 6mm |
Product Code | LWZ |
FDA Device Classification | Class 3 Medical Device |