PMA P180011
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S051
- Product code
- NIU
- Decision date
- 2026-01-30
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for the post-approval labeling update to reflect the findings of the EMINENT post-approval study.
Current openFDA PMA Record#
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S060
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2026-01-30
- Decision code
- APPR
- Date received
- 2024-06-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the post-approval labeling update to reflect the findings of the EMINENT post-approval study.