PMA P170042S014
- Device
- Covera™ Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S014
- Product code
- PFV
- Decision date
- 2025-12-16
- Classification
- Cardiovascular
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- changes to the stent electropolishing and final stent cleaning processes
Current openFDA PMA Record#
- Device
- Covera™ Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S014
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2025-12-16
- Decision code
- OK30
- Date received
- 2025-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the stent electropolishing and final stent cleaning processes