PMA P180011S052
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S052
- Product code
- NIU
- Decision date
- 2023-04-10
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval to update the labeling to include the long-term results of the IMPERIAL continued follow-up and REGAL post-approval studies
Current openFDA PMA Record#
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S052
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2023-04-10
- Decision code
- APPR
- Date received
- 2022-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to update the labeling to include the long-term results of the IMPERIAL continued follow-up and REGAL post-approval studies