PMA P180003S006
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S006
- Product code
- NIP
- Decision date
- 2022-04-05
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Retain stents in production following an in-process quality control test.
Current openFDA PMA Record#
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S006
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-04-05
- Decision code
- OK30
- Date received
- 2022-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Retain stents in production following an in-process quality control test.