HMSC Version 3.63

FDA registration

BIOTRONIK, INC.·11 products·🇺🇸 United States

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR ICD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR/DR AND PARADYM RF VR/DR ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD pulse generator (PG) Models A209/A219

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS

FDA Pre-Market Approval

PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.