PMA P180011S022
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S022
- Product code
- NIU
- Decision date
- 2020-02-06
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Modification of incoming raw material testing and specifications for PVDF-HFP.
Current openFDA PMA Record#
- Device
- Eluvia Drug-Eluting Vascular Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P180011
- Supplement
- S022
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2020-02-06
- Decision code
- OK30
- Date received
- 2020-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of incoming raw material testing and specifications for PVDF-HFP.