PMA P180011S056
- Device
- Eluvia Drug Eluting Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S056
- Product code
- NIU
- Decision date
- 2023-09-21
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval of the revised protocol to shorten follow-up for the post-approval study (PAS)
Current openFDA PMA Record#
- Device
- Eluvia Drug Eluting Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S056
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2023-09-21
- Decision code
- APPR
- Date received
- 2023-08-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol to shorten follow-up for the post-approval study (PAS)