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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.
 
DevicePROCOL VASCULAR BIOPROSTHESIS
Classification Nametissue graft of 6mm and greater
Generic Nametissue graft of 6mm and greater
Applicant
LEMAITRE VASCULAR INC
63 second avenue
burlington, MA 01803
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 
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