PMA N16837S028
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S028
- Product code
- LXA
- Decision date
- 2022-10-14
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- Implementation of Bacterial Endotoxin Testing (BET) as a product release requirement for the Artegraft Collagen Vascular Graft.
Current openFDA PMA Record#
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S028
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2022-10-14
- Decision code
- OK30
- Date received
- 2022-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of Bacterial Endotoxin Testing (BET) as a product release requirement for the Artegraft Collagen Vascular Graft.