GORE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S067 · decided 2014-10-21
Approval details
- PMA number
- P040043
- Supplement
- S067
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- GORE TAG THORACIC ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2014-07-18
- Decision date
- 2014-10-21
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE GORE TAG THORACICENDOPROSTHESIS TO REFLECT THE FINDINGS OF THE POST-APPROVAL STUDY.
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