PMA N16837S019
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S019
- Product code
- LXA
- Decision date
- 2016-04-04
- Classification
- Tissue Graft Of 6mm And Greater
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- Approval for the use of new polymers for the button and rod that are used in the primary packaging system for this device.
Current openFDA PMA Record#
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S019
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2016-04-04
- Decision code
- APPR
- Date received
- 2015-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of new polymers for the button and rod that are used in the primary packaging system for this device.