GORE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S019 · decided 2009-03-04
Approval details
- PMA number
- P040043
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GORE TAG THORACIC ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2007-10-22
- Decision date
- 2009-03-04
- Days to decision
- 499 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE WITH CLINICAL DATA ON SUBJECTS WITH RUPTURED ANEURYSMS OF THE DESCENDING THORACIC AORTA.
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| 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 |