ARTEGRAFT COLLAGEN VASCULAR GRAFT
FDA premarket approval N16837/S021 · decided 2016-01-19
Approval details
- PMA number
- N16837
- Supplement
- S021
- Supplement type
- Real-Time Process
- Trade name
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2015-09-11
- Decision date
- 2016-01-19
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- APPROVAL FOR INCLUDING A NON-ANTIGENIC STATEMENT IN THE INSTRUCTIONS FOR USE.
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