|
Device | ARTEGRAFT COLLAGEN VASCULAR GRAFT |
Generic Name | Tissue graft of 6mm and greater |
Applicant | LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803 |
PMA Number | N16837 |
Supplement Number | S005 |
Date Received | 11/03/2006 |
Decision Date | 02/16/2007 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PRIMARY PACKAGE AND TO THE SHRINK SEAL. |