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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35M
In Commercial Distribution

  • 05415067032508 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-SP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35S
In Commercial Distribution

  • 05415067032492 ()
TENDV-SP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33M
In Commercial Distribution

  • 05415067032485 ()
TENDV-SP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33S
In Commercial Distribution

  • 05415067032478 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33C
In Commercial Distribution

  • 05415067032461 ()
TENDV-SP-33C

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33B
In Commercial Distribution

  • 05415067032454 ()
TENDV-SP-33B

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33A
In Commercial Distribution

  • 05415067032447 ()
TENDV-SP-33A

  • Mitral transcatheter heart valve bioprosthesis
X EP System Surface Electrode Kit
ST. JUDE MEDICAL, INC.
ENSITE-SEK-5-01
In Commercial Distribution

  • 05415067032379 ()
  • 15415067032376 ()
ENSITE-SEK-5-01

  • Cardiac mapping system reference patch
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
PRCN-SEK-A
In Commercial Distribution

  • 05415067032355 ()
  • 15415067032352 ()
PRCN-SEK-A

  • Cardiac mapping system reference patch
Locating Electrodes
ST. JUDE MEDICAL, INC.
SURF-ELEC-2PRS
In Commercial Distribution

  • 05415067032300 ()
SURF-ELEC-2PRS

  • Cardiac mapping system reference patch
Steerable Catheter with Electrodes
ST. JUDE MEDICAL, INC.
DS3H010-38
In Commercial Distribution

  • 05415067032287 ()

  • Catheter Gauge: 10.5000 French
DS3H010-38

  • Vascular guide-catheter, single-use
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-CF-01
In Commercial Distribution

  • 05415067032256 ()
ENSITE-D-CF-01

  • Cardiac mapping system application software
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-CF-01
In Commercial Distribution

  • 05415067032249 ()
ENSITE-CF-01

  • Cardiac mapping system application software
Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-3MC-01
In Commercial Distribution

  • 05415067032225 ()
ENSITE-FF-3MC-01

  • Electrical-only medical device connection cable, reusable
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVTR-23
In Commercial Distribution

  • 05415067031570 ()

  • Outer Diameter: 23.0000 Millimeter
NVTR-23

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Loading System
ST. JUDE MEDICAL, INC.
FNAV-LS-LG
In Commercial Distribution

  • 05415067031440 ()
FNAV-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3662
In Commercial Distribution

  • 05415067031426 ()
3662

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
System Reference Electrode
ST. JUDE MEDICAL, INC.
SYS-REF-V1
In Commercial Distribution

  • 05415067031402 ()
SYS-REF-V1

  • Cardiac mapping system reference patch
Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-LG
In Commercial Distribution

  • 05415067031389 ()

  • Catheter Gauge: 19.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-LG

  • Transcatheter heart valve bioprosthesis implantation catheter
Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-SM
In Commercial Distribution

  • 05415067031372 ()

  • Catheter Gauge: 18.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-SM

  • Transcatheter heart valve bioprosthesis implantation catheter
Patient Care System (PCS)
ST. JUDE MEDICAL, INC.
2
In Commercial Distribution

  • 05415067031174 ()
MER3700

  • Multiple active implantable device programmer
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDAP-05-04-L
In Commercial Distribution

  • 05415067031044 ()

  • Outer Diameter: 5.0000 Millimeter
9-PDAP-05-04-L

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDAP-04-04-L
In Commercial Distribution

  • 05415067031013 ()

  • Outer Diameter: 4.0000 Millimeter
9-PDAP-04-04-L

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDAP-03-06-L
In Commercial Distribution

  • 05415067030993 ()

  • Outer Diameter: 3.0000 Millimeter
9-PDAP-03-06-L

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDAP-03-04-L
In Commercial Distribution

  • 05415067030986 ()

  • Outer Diameter: 3.0000 Millimeter
9-PDAP-03-04-L

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDAP-03-02-L
In Commercial Distribution

  • 05415067030979 ()

  • Outer Diameter: 3.0000 Millimeter
9-PDAP-03-02-L

  • Cardiac defect occluder
Intravascular Delivery System
ST. JUDE MEDICAL, INC.
9-ATV12F45/80
In Commercial Distribution

  • 05415067030955 ()

  • Catheter Gauge: 12.0000 French
  • Length: 80.0000 Centimeter
9-ATV12F45/80

  • Cardiac occluder delivery kit
Intravascular Delivery System
ST. JUDE MEDICAL, INC.
9-ATV10F45/80
In Commercial Distribution

  • 05415067030948 ()

  • Length: 80.0000 Centimeter
  • Catheter Gauge: 10.0000 French
9-ATV10F45/80

  • Cardiac occluder delivery kit
Intravascular Delivery System
ST. JUDE MEDICAL, INC.
9-ATV09F45/80
In Commercial Distribution

  • 05415067030931 ()

  • Catheter Gauge: 9.0000 French
  • Length: 80.0000 Centimeter
9-ATV09F45/80

  • Cardiac occluder delivery kit
Intravascular Delivery System
ST. JUDE MEDICAL, INC.
9-ATV08F45/80
In Commercial Distribution

  • 05415067030924 ()

  • Catheter Gauge: 8.0000 French
  • Length: 80.0000 Centimeter
9-ATV08F45/80

  • Cardiac occluder delivery kit
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