|
Device | REPEL-CV BIORESORBABLE ADHESION BARRIER |
Generic Name | Barrier, adhesion, cardiovascular |
Applicant | PATHFINDER CELL THERAPY INC. 12 BOW STREET CAMBRIDGE, MA 02138 |
PMA Number | P070005 |
Date Received | 01/30/2007 |
Decision Date | 03/06/2009 |
Withdrawal Date
|
11/03/2015 |
Product Code |
OBD |
Docket Number | 09M-0135 |
Notice Date | 03/11/2009 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S003 |