PMA N16837S023
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S023
- Product code
- LXA
- Decision date
- 2018-01-18
- Classification
- Tissue Graft Of 6mm And Greater
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- Addition of an alternate supplier for bovine carotid arteries.
Current openFDA PMA Record#
- Device
- Artegraft Collagen Vascular Graft
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S023
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2018-01-18
- Decision code
- OK30
- Date received
- 2017-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for bovine carotid arteries.