GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS
FDA premarket approval P040043/S077 · decided 2015-09-10
Approval details
- PMA number
- P040043
- Supplement
- S077
- 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
- 2015-08-11
- Decision date
- 2015-09-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- USE OF AN ALTERNATE PTFE RESIN IN THE SEALING CUFF AND GRAFT COMPONENTS.
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