PMA P060002S039
- Device
- Flair Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S039
- Product code
- PFV
- Decision date
- 2017-07-19
- 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
- Upgrade the sterilization control system for sterilization line #1 at Bard Regional Sterilization, Covington Facility.
Current openFDA PMA Record#
- Device
- Flair Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S039
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2017-07-19
- Decision code
- OK30
- Date received
- 2017-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade the sterilization control system for sterilization line #1 at Bard Regional Sterilization, Covington Facility.