Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGs

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3, SYNERGY, RESTORE PRIME & PRIME ADVANCED FAMILY OF IPGS OR IMPLANTABLE NEUROSTIMULATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generator (IPG) Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST,ELITE,MINUET,PRELUDE,THERA,PRODIGY,PREVA, J EWEL,AND REVEAL FAMILIES OF IPGS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG)

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

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE, CONSULTA CRT-P, INSYNC IPG, SYNCRA CRT-P AND VIVA CRT-P

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900/ RELIA/SIGMA/ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPGS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi

HD 60145133 0001

Certificate

MDD Annex II (excluding section 4)·MEDICAL IP Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

PX France Sàrl

Authorized representative

🇫🇷 France·2 Manufacturers

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia, Advisa, Astra, Attesta, Azure, Relia, Sphera, DR S XT SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS, GENESISXP/DUAL XP, GENESISRC, GENESIS DUAL 4-CHANNEL, EON, EONC, AND EONMINI NEUROSTIMULATION (IPG) SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG ADDR01, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, ADSR01, ADVDD01;

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG ADDR01, ADSR01, ADDR03, ADVDD01, ADDRS1, ADSR03, SEDR01, ADDR06, ADDRL1, ADSR06, SESR01, VEDR0