ARTEGRAFT BOVINE HETEROGRAFT
FDA premarket approval N16837/S003 · decided 2000-02-11
Approval details
- PMA number
- N16837
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARTEGRAFT BOVINE HETEROGRAFT
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 1999-07-29
- Decision date
- 2000-02-11
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Approval of a manufacturing site located at Artegraft, Inc., North Brunswick NJ.
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