Itrevia 5 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479128852·

SOFT TISSUE GUIDE DRT

FDA UDI

Biomet Orthopedics, LLC·00887868073083·

Ilivia 7 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479142100·

Ilesto 5 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479125226·

Lumax 740 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479110253·

Ilesto 7 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479125189·

Rivacor 7 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479156794·

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725, VERSION 2.2

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE

Intica Neo 5 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479156947·

Intica Neo 7 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479156848·

Ilivia Neo 7 DR-T

FDA UDI

BIOTRONIK SE & Co. KG·04035479156749·

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·lesto 7 DR-T, lperia 7 DR-T, lforia 7 DR-T, lnventra 7 DR-T, llesto 5 DR-T, ltrevia 5 DR-T, lforia 5 DR-T, lperia 5 DR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T, PHILOSII DR-T AND CYLOS DR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.