PMA P130006S032
- Device
- GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S032
- Product code
- PFV
- Decision date
- 2016-09-21
- 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
- Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.
Current openFDA PMA Record#
- Device
- GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P130006
- Supplement
- S032
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2016-09-21
- Decision code
- OK30
- Date received
- 2016-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.