BioMimics 3D® Vascular Stent
FDA premarket approval P180003/S009 · decided 2024-05-10
Approval details
- PMA number
- P180003
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BioMimics 3D® Vascular Stent
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2024-04-26
- Decision date
- 2024-05-10
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- changes to the instructions for use and other labelling in intended to enhance the safe in-use of the device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.