| Device Type ID | 4725 |
| Device Name | Acid, Hyaluronic, Intraarticular |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MOZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4725 |
| Device | Acid, Hyaluronic, Intraarticular |
| Product Code | MOZ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 894 |
Device Contamination With Biological Material | 679 |
Microbial Contamination Of Device | 106 |
Appropriate Term/Code Not Available | 40 |
No Apparent Adverse Event | 21 |
Insufficient Information | 13 |
Off-Label Use | 4 |
Loss Of Data | 4 |
Patient-Device Incompatibility | 4 |
Missing Value Reason | 3 |
Contamination Of Device Ingredient Or Reagent | 2 |
Inaccurate Delivery | 1 |
Aborted Charge | 1 |
Device Operates Differently Than Expected | 1 |
Use Of Device Problem | 1 |
Invalid Sensing | 1 |
| Total Device Problems | 1775 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sanofi Genzyme | II | Feb-14-2018 |