This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the post-approval study protocol.
| Device | REPEL-CV |
| Generic Name | Barrier, Adhesion, Cardiovascular |
| Applicant | PATHFINDER CELL THERAPY INC. |
| Date Received | 2011-03-07 |
| Decision Date | 2011-05-05 |
| PMA | P070005 |
| Supplement | S002 |
| Product Code | OBD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PATHFINDER CELL THERAPY INC. 12 Bow Street cambridge, MA 02138 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070005 | Original Filing | |
| S002 | 2011-03-07 | Normal 180 Day Track No User Fee |
| S001 |