FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002/S028 · decided 2012-10-04
Approval details
- PMA number
- P060002
- Supplement
- S028
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2012-09-27
- Decision date
- 2012-10-04
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- 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.
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