Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICD'S

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY

FDA Pre-Market Approval

INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M

FDA Pre-Market Approval

INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS

FDA Pre-Market Approval

BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD MODELS, INCEPTA E-160, E-161, E162, E163, ENERGEN E140, E141, E142, E143, PUNCTUA E050, E050, E051, E052, E053

FDA Pre-Market Approval

INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS

FDA Pre-Market Approval

CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM VR, PRIZM DR, PRIZM HE VR, PRIZM HE DR, PRIZM 2 VE, PRIZM 2 DR, PRIZM AT ICDS

FDA Pre-Market Approval

INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/CONCERTO II/MAXIMO II/CONSULTA CRT-DS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR

FDA Pre-Market Approval

INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG

FDA Pre-Market Approval

INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DS

1434-IVDD-198/2022

Certificate

IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-199/2022

Certificate

IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

FDA Pre-Market Approval

INSYNC/INSYNC MARQUIS II/III/INSYNC PROTECT II/III/INSYNC SENTRY & MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS