GORE TAG THORACIC ENDOPROSTESIS
FDA premarket approval P040043/S037 · decided 2011-02-24
Approval details
- PMA number
- P040043
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GORE TAG THORACIC ENDOPROSTESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2010-09-02
- Decision date
- 2011-02-24
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL TO UPDATE THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE TO INCLUDE SUMMARY INFORMATION ON THE EVALUATION OF THE PHYSICIAN TRAINING PROGRAM FOR THIS DEVICE.
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