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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS

Medisono

FDA UDI

Medisono, LLC·B369MUS05180·Probe

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T

Lumax

FDA registration

BIOTRONIK, INC.·7 products·🇺🇸 United States

Lumax

FDA registration

BIOTRONIK SE & CO. KG·7 products·🇩🇪 Germany

Enzyme Immunoassay, Fetal Fibronectin

FDA classification

FDA Class 3 ·Enzyme Immunoassay, Fetal Fibronectin

Apparatus, Vestibular Analysis

FDA classification

FDA Unclassified ·Apparatus, Vestibular Analysis

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

FDA Pre-Market Approval

FDA Class 3 ·FINISHING WIRE UNIVERSAL

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

PRO-TECH DESIGN & MFG., INC.

FDA registration

PRO-TECH DESIGN & MFG., INC.·7 products·🇺🇸 United States

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

Abbott Medical·7 products·🇺🇸 United States

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

FDA registration

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.·7 products·🇭🇰 Hong Kong

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

Abbott Medical·7 products·🇺🇸 United States

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

Amphenol Medical Technologies (Dongguan) Co., Ltd.

FDA registration

Amphenol Medical Technologies (Dongguan) Co., Ltd.·7 products·🇨🇳 China

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·7 products·🇺🇸 United States

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

St. Jude Medical Coordination Center BVBA European Distribution Center·7 products·🇧🇪 Belgium