BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S002 · decided 2020-04-10
Approval details
- PMA number
- P180003
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BioMimics 3D Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2020-03-16
- Decision date
- 2020-04-10
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- In-process stent quality control changes, a component supplier manufacturing location change and part number changes.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.