PMA P060002S020
- Device
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S020
- Product code
- PFV
- Decision date
- 2011-09-22
- 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
- USE OF A NEW MOLD MADE FROM A DIFFERENT MATERIAL FOR MANUFACTURE OF A CRITICAL DEVICE COMPONENT.
Current openFDA PMA Record#
- Device
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S020
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2011-09-22
- Decision code
- OK30
- Date received
- 2011-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A NEW MOLD MADE FROM A DIFFERENT MATERIAL FOR MANUFACTURE OF A CRITICAL DEVICE COMPONENT.