PMA N16837S008
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S008
- Product code
- LXA
- Decision date
- 2012-01-10
- Classification
- Tissue Graft Of 6mm And Greater
- Generic name
- Tissue graft of 6mm and greater
- Approval order statement
- UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
Current openFDA PMA Record#
- Device
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Applicant
- LeMaitre Vascular, Inc.
- PMA number
- N16837
- Supplement
- S008
- Product code
- LXA
- Generic name
- Tissue graft of 6mm and greater
- Decision date
- 2012-01-10
- Decision code
- APPR
- Date received
- 2011-09-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.