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 Ave.; 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
• Predetermined Change Control Plan Authorized: No
• Supplements: S001 S005 S021 S008 S003 S006 S004 S022 S026 S030 S031 ; S035 S034 S025 S023 S024 S033 S032 S036 S010 S019 S015 S012 ; S020 S009 S007 S011 S017 S018 S014 S029 S028