HSA · registration DE0508589Abbott Medical Epic Stented Tissue Valve
- Registration number
- DE0508589
- Model name
- Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Stented Tissue Valve; Epic Plus Heart Valve Sizer Set; Holder Handle, Model E2000-HA; Holder Handle, Model E2000-HM; Epic Max Heart Valve Sizer Set; Epic Max Stented Tissue Valve; Epic Max Stented Tissue Valve; Epic Max Stented Tissue Valve; Epic Max Stented Tissue Valve; Epic Max Stented Tissue Valve; Epic Plus Supra Stented Tissue Valve; Epic Plus Supra Stented Tissue Valve; Epic Plus Supra Stented Tissue Valve; Epic Plus Supra Stented Tissue Valve; Epic Plus Supra Stented Tissue Valve
- Model identifier
- E200-21A; E200-23A; E200-25A; E200-25M; E200-27A; E200-27M; E200-29A; E200-29M; E200-31M; E200-33M; E2000; E2000-HA; E2000-HM; EMAX-1000; EMAX-19; EMAX-21; EMAX-23; EMAX-25; EMAX-27; ESP200-19; ESP200-21; ESP200-23; ESP200-25; ESP200-27
- Registration date
- October 20, 2023
- Source update date
- August 28, 2025
- Risk class
- Class D
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
The Epic Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. The Epic Plus Supra valve and Epic Max valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.
- Product owner address
- 177 County Road B East, St. Paul, Minnesota 55117, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.