|
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 | S020 |
Date Received | 04/01/2015 |
Decision Date | 04/29/2015 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX. |