ARTEGRAFT COLLAGEN VASCULAR GRAFT
FDA premarket approval N16837/S015 · decided 2014-07-14
Approval details
- PMA number
- N16837
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2014-07-07
- Decision date
- 2014-07-14
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- APPROVAL FOR A LABELING CHANGE TO MODIFY THE SIZING CONVENTION FROM OUTER DIAMETER TO INNER DIAMETER OF THE GRAFT.
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