PMA P180011S053
- Device
- Eluvia™ Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S053
- Product code
- NIU
- Decision date
- 2023-02-16
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Additional ovens used for delivery system component manufacturing at a supplier.
Current openFDA PMA Record#
- Device
- Eluvia™ Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S053
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2023-02-16
- Decision code
- OK30
- Date received
- 2023-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional ovens used for delivery system component manufacturing at a supplier.