PMA P180003S014
- Device
- BioMimics 3D® Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S014
- Product code
- NIP
- Decision date
- 2026-02-19
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- changes to the stent surface finish inspection criteria on stents lengths from 60mm to 125 mm
Current openFDA PMA Record#
- Device
- BioMimics 3D® Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S014
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-02-19
- Decision code
- OK30
- Date received
- 2026-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the stent surface finish inspection criteria on stents lengths from 60mm to 125 mm