|
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 | S007 |
Date Received | 06/22/2009 |
Decision Date | 07/21/2009 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement MODIFICATION TO THE QUALITY CONTROL SAMPLING PLAN FOR A PORTION OF FINISHED DEVICE TESTING. |