PMA P180011S070
- Device
- ELUVIA™ Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S070
- Product code
- NIU
- Decision date
- 2026-08-21
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites
Current openFDA PMA Record#
- Device
- ELUVIA™ Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S070
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2026-08-21
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites