Device Type ID | 1018 |
Device Name | Device. Laser Peripheral Angioplasty |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LWX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1018 |
Device | Device. Laser Peripheral Angioplasty |
Product Code | LWX |
FDA Device Classification | Class 3 Medical Device |