ARTEGRAFT COLLAGEN VASCULAR GRAFT
FDA premarket approval N16837/S019 · decided 2016-04-04
Approval details
- PMA number
- N16837
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2015-03-06
- Decision date
- 2016-04-04
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Approval for the use of new polymers for the button and rod that are used in the primary packaging system for this device.
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|---|---|---|
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| Antegrade LeMills Valvulotome (K142660) | LeMaitre Vascular, Inc. | 2014-10-17 |
| 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042) | LeMaitre Vascular, Inc. | 2014-04-10 |
| UNBALLOON NON-OCCLUSION MODELING CATHETER (K133026) | LeMaitre Vascular, Inc. | 2013-12-31 |