PMA N16837S015
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S015
- Product code
- LXA
- Decision date
- 2014-07-14
- Classification
- Tissue Graft Of 6mm And Greater
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO MODIFY THE SIZING CONVENTION FROM OUTER DIAMETER TO INNER DIAMETER OF THE GRAFT.
Current openFDA PMA Record#
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S015
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2014-07-14
- Decision code
- APPR
- Date received
- 2014-07-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO MODIFY THE SIZING CONVENTION FROM OUTER DIAMETER TO INNER DIAMETER OF THE GRAFT.