- Device
- GORE VIABAHN ENDOPROSTHESIS; GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S087
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2015-12-02
- Decision code
- OK30
- Date received
- 2015-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO IMPLEMENT A PROCESS SETTING CHANGE FOR THE RADIO FREQUENCY INDUCTION BONDER MACHINE (RF BONDER).