Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR-

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1704.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1801.U

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Solia S Leads

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1901.U

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, VIGILA, VOLTA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 3XO/5X10

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW STEROID LV LEAD MONITORING (COSMO)

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO FAMILY OF ICD LEADS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families