Artegraft Collagen Vascular Graft
FDA premarket approval N16837/S031 · decided 2023-06-29
Approval details
- PMA number
- N16837
- Supplement
- S031
- 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
- 2023-05-30
- Decision date
- 2023-06-29
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Implementation of changes to the purified water testing protocol for manufacturing of the Artegraft Collagen Vascular Graft.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |