Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: REPEL-CV
• Classification Name: barrier, adhesion, cardiovascular
• Applicant: PATHFINDER CELL THERAPY INC.
• PMA Number: P070005
• Supplement Number: S002
• Date Received: 03/07/2011
• Decision Date: 05/05/2011
• Product Code: OBD [ Registered Establishments with OBD ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.