Definition: Preparation Of Concentrated Bone Marrow Aspirate (cBMA) From A Sample Of Bone Marrow For Clinical Use
| Device Type ID | 2510 |
| Device Name | Bone Marrow Processing Device For Clinical Use |
| Physical State | May Include Centrifuge, Filters, Tubes, Syringes, Needles, Other Disposables And Anticoagulant |
| Technical Method | Uses Centifugal And/or Filtration Methods To Separate The Bone Marrow Into Components, After Which The Concentrated Bone Marrow Cells Are Withdrawn |
| Target Area | Bone Marrow Drawn From Iliac Crest Or Other Bone Marrow Cavity, CBMA Applied Clinically |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PZU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |