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: PROCOL VASCULAR BIOPROSTHESIS
• Classification Name: tissue graft of 6mm and greater
• Applicant: HANCOCK/JAFFE LABORATORIES
• PMA Number: P020049
• Supplement Number: S001
• Date Received: 09/17/2009
• Decision Date: 10/08/2009
• Product Code: LXA [ Registered Establishments with LXA ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate abattoir.