BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S005 · decided 2022-03-01
Approval details
- PMA number
- P180003
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- 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
- 2021-10-14
- Decision date
- 2022-03-01
- Days to decision
- 138 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- Approval for the addition of an alternative sterilization site located at Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, addition of a new sterilization cycle, an alternative load configuration and ability to perform endotoxin testing on non-sterile samples in the current laboratory.
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