This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the repel-cv bioresorbable adhesion barrier. The device is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy.
| Device | REPEL-CV BIORESORBABLE ADHESION BARRIER |
| Generic Name | Barrier, Adhesion, Cardiovascular |
| Applicant | PATHFINDER CELL THERAPY INC. |
| Date Received | 2007-01-30 |
| Decision Date | 2009-03-06 |
| Notice Date | 2009-03-11 |
| PMA | P070005 |
| Supplement | S |
| Product Code | OBD |
| Docket Number | 09M-0135 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PATHFINDER CELL THERAPY INC. 12 Bow Street cambridge, MA 02138 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070005 | Original Filing | |
| S002 | 2011-03-07 | Normal 180 Day Track No User Fee |
| S001 |