PMA P170042S003
- Device
- Covera Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S003
- Product code
- PFV
- Decision date
- 2019-10-31
- 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
- Approval of the protocols for the post-approval studies (PAS) protocol.
Current openFDA PMA Record#
- Device
- Covera Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S003
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2019-10-31
- Decision code
- APPR
- Date received
- 2019-04-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocols for the post-approval studies (PAS) protocol.