PMA P130006S027
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S027
- Product code
- PFV
- Decision date
- 2016-02-04
- Classification
- System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.
Current openFDA PMA Record#
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S027
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2016-02-04
- Decision code
- OK30
- Date received
- 2016-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.