Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}
• Generic Name: Tissue graft of 6mm and greater
• Applicant: LeMaitre Vascular, Inc.; 63 Second Avenue; Burlington, MA 01803
• PMA Number: N16837
• Date Received: 07/01/1979
• Decision Date: 08/01/1979
• Product Code: LXA
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 ; S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 ; S028 S029 S030 S031 S032