220187
Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic
假体、心脏瓣膜、生物瓣膜、组织小叶、经导管、主动脉
St. Jude Medical·IV·Hong Kong MDACS·Registered June 29, 2022
Device overview
- Risk class
- IV
- Product code
- 33937
- State
- current
- Status
- N/A
- Product code detail
- 33937 Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic
Manufacturer (製造商)
- Name
- St. Jude MedicalSt. Jude Medical
- Country
- United States美国
- Address
- 177 County Road B East, St. Paul, Minnesota, 55117 USA177 County Road B East, 圣保罗, 明尼苏达州, 55117 美国
Authorised representative (AR)
- Name
- Abbott Medical (Hong Kong) Limited美国雅培医疗用品(香港)有限公司
- Phone
- 29967688
Regulatory timeline
- Registration date
- June 29, 2022
- Expiry date
- June 29, 2027
Product models
Navitor Transcatheter Heart Valve (NVTR-23, NVTR-25, NVTR-27, NVTR-29), Navitor Loading System (NVTR-LS-SM, NVTR-LS-LG), FlexNav Delivery System (FNAV-DS-SM, FNAV-DS-LG)
Navitor 经导管心脏瓣膜 (NVTR-23, NVTR-25, NVTR-27, NVTR-29), Navitor Load System (NVTR-LS-SM, NVTR-LS-LG), FlexNav Delivery System (FNAV-DS-SM, FNAV-DS-LG)
About this record
This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic
產品資訊： 假体、心脏瓣膜、生物瓣膜、组织小叶、经导管、主动脉