PMA N16837S039
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S039
- Product code
- LXA
- Decision date
- 2026-09-04
- Classification
- Cardiovascular
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- Approval of a new warning and other labeling changes in the Instructions for Use for the Artegraft Collagen Vascular Graft
Current openFDA PMA Record#
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S039
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2026-09-04
- Decision code
- APPR
- Date received
- 2026-08-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of a new warning and other labeling changes in the Instructions for Use for the Artegraft Collagen Vascular Graft