PMA P180003S003
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S003
- Product code
- NIP
- Decision date
- 2020-08-13
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for updates to the labeling with final clinical data from the MIMICS-2 study.
Current openFDA PMA Record#
- Device
- BioMimics 3D Vascular Stent System
- Applicant
- Veryan Medical, Ltd.
- PMA number
- P180003
- Supplement
- S003
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-08-13
- Decision code
- APPR
- Date received
- 2020-06-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the labeling with final clinical data from the MIMICS-2 study.