Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Dimension FPSA Flex reagent cartridge

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA, AT500, ENRHYTHM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR/DR MRI IPG; RELIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Micra Transcatheter Pacemaker System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO, SPRINT QUATTRO LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS, Micra AV TPS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Conductr, RF Contactr, RF Marinr, RF Enhancr II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Adapta, Versa Sensia IPG, Advisa DR IPG, Advisa DR /SR MRI IPG, Astra S DR/S SR XTDR/ XT SR M

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SPRINT MODELS 6943/6945