Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Merlin™

FDA UDI

ST. JUDE MEDICAL, INC.·05415067031174·Patient Care System (PCS)

Merlin™

FDA UDI

ST. JUDE MEDICAL, INC.·05415067037121·Software for Merlin 2.0

NA

FDA UDI

ST. JUDE MEDICAL, INC.·05415067040404·MerlinAtHome Software

Merlin™

FDA UDI

ST. JUDE MEDICAL, INC.·05414734509725·Software Upgrade Kit

Merlin.net

FDA UDI

ST. JUDE MEDICAL, INC.·05414734509732·Patient Interactive Website

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA classification

FDA Class 3 ·Pulse-Generator, Single Chamber, Sensor Driven, Implantable

AWO SRL

Manufacturer

🇮🇹 Italy

Leo

FDA registration

PRECISION OPTICS CORP.·1 product·🇺🇸 United States

Pantera LEO

FDA registration

BIOTRONIK APM PTE. LTD·1 product·🇸🇬 Singapore

Pantera LEO

FDA registration

BIOTRONIK AG·1 product·🇨🇭 Switzerland

Pantera LEO

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

Leo Medical Co., Ltd.

Manufacturer

🇨🇳 China·14 Basic UDI-DIs·20 Devices·3 Importers·TÜV SÜD Product Service GmbH

LDO Plus

FDA registration

GENSCO LABORATORIES LLC·1 product·🇺🇸 United States

LaseMD LEO Laser System

FDA registration

CYNOSURE, LLC·1 product·🇺🇸 United States

Leos Laser and Endoscopy System

FDA registration

LINEMASTER SWITCH CORP.·1 product·🇺🇸 United States

LVI Low Vision International AB

Manufacturer

🇸🇪 Sweden

YLite

FDA registration

NORSELD PTY. LTD.·1 product·🇦🇺 Australia

Papain

FDA registration

DIAGAST·1 product·🇫🇷 France

PK SYSTEM CONTROL

FDA registration

DIAGAST·1 product·🇫🇷 France