- Device
- Covera Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S008
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a reduction in the inner diameter of a distal cap of a delivery system joint of the Covera Vascular Covered Stent.