714 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240;
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SYNCHRONY PACING SYS. MODEL 385 FUNCTION PACK
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 700/600 PULSE GENERATOR
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·3500/3510 PROGRAMMER
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PSW 2100.U and NEO 2100.U
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Endurity Core, Endurity, Zenex, Zenus
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Assurity, Assurity+, Endurity families of ICD Devices
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDA-MV PACING SYSTEM