BARD FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002/S010 · decided 2010-09-15
Approval details
- PMA number
- P060002
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2010-03-19
- Decision date
- 2010-09-15
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
| EleVation Breast Biopsy System (K211933) | Bard Peripheral Vascular | 2021-07-15 |
| MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887) | Bard Peripheral Vascular | 2006-10-26 |
| FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041) | Bard Peripheral Vascular | 2003-06-19 |