ARTEGRAFT COLLAGEN VASCULAR GRAFT
FDA premarket approval N16837/S004 · decided 2006-03-02
Approval details
- PMA number
- N16837
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2006-02-01
- Decision date
- 2006-03-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY COMPONENT OF THE DEVICE.
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