PMA N16837S029
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S029
- Product code
- LXA
- Decision date
- 2023-01-25
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- Add alternative facilities for routine sterility testing and bioburden testing of the Artegraft Collagen Vascular Graft product line.
Current openFDA PMA Record#
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S029
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2023-01-25
- Decision code
- OK30
- Date received
- 2022-12-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternative facilities for routine sterility testing and bioburden testing of the Artegraft Collagen Vascular Graft product line.