Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 03

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2303.U, NEO 2303.U

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF –T QP, Rivacor 5 HF –T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER SMART

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non- Crt)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar/Pulsar - 18 Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-Chambe

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18)