PMA P130029S012
- Device
- Fluency™ Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S012
- Product code
- PFV
- Decision date
- 2023-02-17
- Classification
- Cardiovascular
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- Implementation of an additional stent cutting laser.
Current openFDA PMA Record#
- Device
- Fluency™ Endovascular Stent Graft
- Applicant
- Bard Peripheral Vascular, Inc.
- PMA number
- P130029
- Supplement
- S012
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2023-02-17
- Decision code
- OK30
- Date received
- 2023-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an additional stent cutting laser.