Definition: Indicated To Reduce The Incidence, Severity Or Extent Of Adhesions/tissue Attachment In Cardiovascular Surgery By Providing A Plane Of Dissection Or Mechanical Barrier Between Opposing Surfaces Of Tissue And/or Devices. Intended For Use In Cardiac Su
| Device Type ID | 1065 |
| Device Name | Barrier, Adhesion, Cardiovascular |
| Physical State | A Resorbable Synthetic Polymeric Material That Is Either A Sheet Of Material Or A Spray Liquid |
| Technical Method | The Barrier May Be Either Placed In The Area Of Concern, Or Sutured In Place, Or Sprayed Onto The Area |
| Target Area | Thoracic Region |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OBD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1065 |
| Device | Barrier, Adhesion, Cardiovascular |
| Product Code | OBD |
| FDA Device Classification | Class 3 Medical Device |