Artegraft Collagen Vascular Graft
FDA premarket approval N16837/S025 · decided 2018-07-12
Approval details
- PMA number
- N16837
- Supplement
- S025
- 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
- 2018-06-15
- Decision date
- 2018-07-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Addition of an alternate supplier for a raw material used in processing of the Artegraft.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PhasTIPP (K212894) | LeMaitre Vascular, Inc. | 2022-03-31 |
| XenoSure Dura Biologic Patch (K183513) | LeMaitre Vascular, Inc. | 2019-06-13 |
| AnastoClip GC Closure System (K173323) | LeMaitre Vascular, Inc. | 2018-03-08 |
| Pruitt F3-S Polyurethane Carotid Shunt (K152833) | LeMaitre Vascular, Inc. | 2016-01-21 |
| Pruitt F3-S Carotid Shunt (K143454) | LeMaitre Vascular, Inc. | 2015-08-27 |
| 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 |