PMA P040027S035
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S035
- Product code
- MIR
- Decision date
- 2014-07-02
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S035
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2014-07-02
- Decision code
- OK30
- Date received
- 2014-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP AND USP .