GORE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S023 · decided 2008-08-20
Approval details
- PMA number
- P040043
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2008-05-30
- Decision date
- 2008-08-20
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE DEVICE.
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