PMA P060002S028
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S028
- Product code
- PFV
- Decision date
- 2012-10-04
- 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 FOR THE INCORPORATION OF A NEW LEICA DM2500M MICROSCOPE AND DFC295 DIGITAL CAMERA TO INCREASE IMAGE RESOLUTION IN ORDER TO MEASURE MATERIAL POROSITY IN ACCORDANCE WITH ISO 7198.
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S028
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2012-10-04
- Decision code
- APPR
- Date received
- 2012-09-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE INCORPORATION OF A NEW LEICA DM2500M MICROSCOPE AND DFC295 DIGITAL CAMERA TO INCREASE IMAGE RESOLUTION IN ORDER TO MEASURE MATERIAL POROSITY IN ACCORDANCE WITH ISO 7198.