GORE Conformable TAG Thoracic Endoprosthesis
FDA premarket approval P040043/S105 · decided 2018-10-17
Approval details
- PMA number
- P040043
- Supplement
- S105
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE Conformable TAG Thoracic Endoprosthesis
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2018-09-21
- Decision date
- 2018-10-17
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- Implement an additional film attach machine to be used during the manufacture of the GORE Conformable TAG Thoracic Endoprosthesis.
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