GODRE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S060 · decided 2014-06-04
Approval details
- PMA number
- P040043
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GODRE TAG THORACIC ENDOPROSTHESIS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2014-01-14
- Decision date
- 2014-06-04
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR A MODIFICATION TO THE DESTRUCTIVE TESTING SAMPLING PLAN AND CHANGE IN THE DEPLOYMENT FORCE SPECIFICATION.
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