PMA P180003S002
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S002
- Product code
- NIP
- Decision date
- 2020-04-10
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- In-process stent quality control changes, a component supplier manufacturing location change and part number changes.
Current openFDA PMA Record#
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S002
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-04-10
- Decision code
- OK30
- Date received
- 2020-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- In-process stent quality control changes, a component supplier manufacturing location change and part number changes.