PMA P180011S010
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S010
- Product code
- NIU
- Decision date
- 2019-09-06
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Replace the vacuum purge system with a positive pressure purge system.
Current openFDA PMA Record#
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S010
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2019-09-06
- Decision code
- OK30
- Date received
- 2019-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the vacuum purge system with a positive pressure purge system.