PMA P040027S032
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S032
- Product code
- MIR
- Decision date
- 2013-10-04
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S032
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2013-10-04
- Decision code
- OK30
- Date received
- 2013-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.