Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis
FDA premarket approval P020004/S172 · decided 2019-12-20
Approval details
- PMA number
- P020004
- Supplement
- S172
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2019-12-09
- Decision date
- 2019-12-20
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Approval for updates to the Instructions for Use. The updates include modifications to existing warning statements, addition of a new warning statement, addition of new procedural steps and recommended material, and addition of new adverse events that may occur and/or require reintervention or additional procedural time.
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|---|---|---|
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| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |