Device Type ID | 1402 |
Device Name | Material, Dressing, Surgical, Polylactic Acid |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LPG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1402 |
Device | Material, Dressing, Surgical, Polylactic Acid |
Product Code | LPG |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Total Device Problems | 2 |