PMA N16837S007
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S007
- Product code
- LXA
- Decision date
- 2009-07-21
- Classification
- Tissue Graft Of 6mm And Greater
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- MODIFICATION TO THE QUALITY CONTROL SAMPLING PLAN FOR A PORTION OF FINISHED DEVICE TESTING.
Current openFDA PMA Record#
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S007
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2009-07-21
- Decision code
- OK30
- Date received
- 2009-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE QUALITY CONTROL SAMPLING PLAN FOR A PORTION OF FINISHED DEVICE TESTING.