|
Device | PROCOL VASCULAR BIOPROSTHESIS |
Generic Name | Tissue graft of 6mm and greater |
Applicant | LEMAITRE VASCULAR INC 63 SECOND AVENUE BURLINGTON, MA 01803 |
PMA Number | P020049 |
Date Received | 11/12/2002 |
Decision Date | 07/29/2003 |
Withdrawal Date
|
12/15/2023 |
Product Code |
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 S005 S006 S007 |