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Singapore HSA registration DE0502946

Edwards Lifesciences Sapien 3 Certitude Kit

Singapore flagSingapore·CLASS D·Edwards Lifesciences LLC·Registered March 28, 2019
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0502946
Registration Date
March 28, 2019
Change Notification Approval Date
August 02, 2023
Retention Due Date
March 27, 2026
Product description
1. The Edwards SAPIEN 3 system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. 2. The Edwards SAPIEN 3 system is indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Product Owner
Name
Edwards Lifesciences LLC
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Name
EDWARDS LIFESCIENCES (ASIA) PTE. LTD.
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Name
EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD.
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641
Model information
Model Name(s)
Ascendra Balloon Aortic Valvuloplasty Catheter Crimper Edwards SAPIEN 3 Transcatheter Heart Valve Edwards SAPIEN 3 Transcatheter Heart Valve Edwards SAPIEN 3 Transcatheter Heart Valve Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards Certitude Introducer Sheath Set Edwards Certitude Delivery System Edwards Certitude Delivery System Edwards Certitude Delivery System Edwards Certitude Delivery System Edwards Inflation Device Edwards Locking Syringe SAPIEN 3 Certitude Kit SAPIEN 3 Certitude Kit SAPIEN 3 Certitude Kit SAPIEN 3 Certitude Kit
Model Identifier(s)
9100BAVC 9600CR 9600TFX20 9600TFX23 9600TFX26 9600TFX29 9620IS18 9620IS21 9620TA20 9620TA23 9620TA26 9620TA29 96402 96406 S3TA120 S3TA123 S3TA126 S3TA129
About this record

Access comprehensive regulatory information for Edwards Lifesciences Sapien 3 Certitude Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502946 and owned by Edwards Lifesciences LLC. The device was registered on March 28, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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