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

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP(R) RX STEROID ELUTING LEAD

Lens, Contact, (Disposable)

FDA classification

FDA Class 2 ·Lens, Contact, (Disposable)

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

FDA classification

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Relia IPG

FDA registration

MEDTRONIC, INC.·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

ABBOTT MEDICAL·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

Abbott Medical·5 products·🇺🇸 United States

Relia IPG

FDA registration

MEDTRONIC SOFAMOR DANEK USA, INC.·5 products·🇺🇸 United States

PRO-TECH DESIGN & MFG., INC.

FDA registration

PRO-TECH DESIGN & MFG., INC.·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

Abbott Medical·5 products·🇲🇾 Malaysia

Relia IPG

FDA registration

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·5 products·🇺🇸 United States

Relia IPG

FDA registration

Medtronic Europe Sarl·5 products·🇨🇭 Switzerland

Relia IPG

FDA registration

Medtronic Singapore Operations Pte Ltd·5 products·🇸🇬 Singapore

Relia IPG

FDA registration

Medtronic Distribution Center·5 products·🇺🇸 United States

Suture Sleeve Accessory DS2A088

FDA registration

ABBOTT MEDICAL·5 products·🇺🇸 United States

LORCAN & FYON B.V.

Authorized representative

🇳🇱 Netherlands·21 Manufacturers·37 Devices

10167-2017-CE-RGC-NA-PS

Certificate

MDD Annex II (excluding section 4)·Perfect Medical Industry (VN) Co., Ltd·DNV Product Assurance AS·3 Basic UDI-DIs

10167-2017-CE-RGC-NA-PS Rev. 4.0

Certificate

MDD Annex II (excluding section 4)·Perfect Medical Industry (VN) Co., Ltd·DNV Product Assurance AS·1 Basic UDI-DI

Home Monitoring

FDA registration

BIOTRONIK SE & CO. KG·11 products·🇩🇪 Germany

HMSC Version 3.63

FDA registration

BIOTRONIK, INC.·11 products·🇺🇸 United States

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices