GORE VIATORR TIPS ENDOPROSTHESIS
FDA premarket approval P040027/S050 · decided 2016-10-05
Approval details
- PMA number
- P040027
- Supplement
- S050
- Supplement type
- 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
- 2016-09-06
- Decision date
- 2016-10-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Implementation of an alternate vacuum bond oven for use during manufacturing of the VIATORR TIPS Endoprosthesis and VIATORR TIPS Endoprosthesis with Controlled Expansion.
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