GORE VIATORR TIPS ENDOPROSTHESIS
FDA premarket approval P040027/S002 · decided 2005-12-08
Approval details
- PMA number
- P040027
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE VIATORR TIPS ENDOPROSTHESIS
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2005-09-19
- Decision date
- 2005-12-08
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- APPROVAL TO CHANGE CERTAIN MANUFACTURING PROCESSES FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIATORR TIPS ENDOPROSTHESIS AND IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.
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