GORE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S033 · decided 2010-05-25
Approval details
- PMA number
- P040043
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE TAG THORACIC ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2010-01-13
- Decision date
- 2010-05-25
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR A NEW 22 MM CONSTRAINING SLEEVE SIZE TO BE USED IN THE 40 MM DIAMETER TAG DEVICE.
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| 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 |