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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROCOL VASCULAR BIOPROSTHESIS
Classification Nametissue graft of 6mm and greater
ApplicantHANCOCK/JAFFE LABORATORIES
PMA NumberP020049
Date Received11/12/2002
Decision Date07/29/2003
Product Code
LXA[ Registered Establishments with LXA ]
Docket Number 03M-0352
Notice Date 08/07/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the procol vascular bioprosthesis. The device is indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft.
Approval Order Approval Order
Supplements: S001 S002 
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