ClassIII_PMA_implants.csv
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Product Code
DeviceDevice Class
Regulation Number
Regulation Description
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PMXAbsorbable Collagen Hemostatic Agent With Thrombin3[878.4490]Absorbable hemostatic agent and dressing.
3
KGFAdhesive Tissue For Aneurysmorrhaphy3
4
LMFAgent Absorbable Hemostatic Collagen Based3[878.4490]Absorbable hemostatic agent and dressing.
5
LMGAgent Absorbable Hemostatic Non-Collagen Based3[878.4490]Absorbable hemostatic agent and dressing.
6
PJQAgent Occluding Vascular Permanent3
7
NPTAortic Valve Prosthesis Percutaneously Delivered3
8
LOZArtificial Heart3
9
MPCAtrial Defibrillator3[870.5300]DC-defibrillator (including paddles).
10
HFYBand Tubal Occlusion3[884.5380]Contraceptive tubal occlusion device (TOD) and introducer.
11
OBDBarrier Adhesion Cardiovascular3
12
NQABiologic Material Dental3[872.3930]Bone grafting material.
13
NPZBone Grafting Material Dental With Biologic Component3[872.3930]Bone grafting material.
14
NVCBone Heterograft3[888.3015]Bone heterograft.
15
HGBClip Tubal Occlusion3[884.5380]Contraceptive tubal occlusion device (TOD) and introducer.
16
NIQCoronary Drug-Eluting Stent3
17
PFCCultured Human Cell Skin Dressing3
18
NIKDefibrillator Automatic Implantable Cardioverter With Cardiac Resynchronization (Crt-D)3
19
MRMDefibrillator Implantable Dual-Chamber3
20
MDDDevice Dermal Replacement3
21
FHWDevice Impotence Mechanical/Hydraulic3[876.3350]Penile inflatable implant.
22
EZYDevice Incontinence Mechanical/Hydraulic3[876.5280]Implanted mechanical/hydraulic urinary continence device.
23
HDTDevice Intrauterine Contraceptive And Introducer3[884.5360]Contraceptive intrauterine device (IUD) and introducer.
24
KNHDevice Occlusion Tubal Contraceptive Laparoscopic3[884.5380]Contraceptive tubal occlusion device (TOD) and introducer.
25
PMPDorsal Root Ganglion Stimulator For Pain Relief3
26
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode3
27
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes3
28
OWODrug-Eluting Sinus Stent3
29
LHYElectrode Stabilized Epidural Spinal3
30
NEKFiller Recombinant Human Bone Morphogenetic Protein Collagen Scaffold With Metal Prosthesis Osteoinduction3
31
NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis3
32
MUQGlue Surgical Arteries3
33
LWQHeart-Valve Mechanical3
34
LWRHeart-Valve Non-Allograft Tissue3
35
PGQHybrid Cochlear Implant3
36
LEIImplant Anti-Gastroesophageal Reflux3
37
MHEImplant Auditory Brainstem3
38
MCMImplant Cochlear3
39
LMIImplant Collagen For Non-Aesthetic Use3
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LMHImplant Dermal For Aesthetic Use3
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PKYImplant Dermal For Aesthetic Use In The Hands3
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MPVImplant Hearing Active Middle Ear Partially Implanted3
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OAFImplant Hearing Active Middle Ear Totally Implanted3
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LTIImplant Intragastric For Morbid Obesity3
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LWSImplantable Cardioverter Defibrillator (Non-Crt)3
46
DXYImplantable Pacemaker Pulse-Generator3[870.3610]Implantable pacemaker pulse generator.
47
LWPImplantable Pulse Generator Pacemaker (Non-Crt)3
48
PFNImplanted Brain Stimulator For Epilepsy3
49
GZAImplanted Cerebellar Stimulator3[882.5820]Implanted cerebellar stimulator.
50
GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator3[882.5830]Implanted diaphragmatic/phrenic nerve stimulator.
51
MIPImplanted Fecal Incontinence Device3
52
HHSInsert Tubal Occlusion3[884.5380]Contraceptive tubal occlusion device (TOD) and introducer.
53
MPJInterarticular Disc Prosthesis (Interpositional Implant)3[872.3970]Interarticular disc prosthesis (interpositional implant).
54
OUTIntracranial Aneurysm Flow Diverter3
55
HQLIntraocular Lens3[886.3600]Intraocular lens.
56
OGOIntraocular Pressure Lowering Implant3
57
LZDJoint Temporomandibular Implant3[872.3940]Total temporomandibular joint prosthesis.
58
PNJLeadless Pacemaker3[870.3610]Implantable pacemaker pulse generator.
59
MTALens Intraocular Phakic3
60
MJPLens Intraocular Toric Optics3[886.3600]Intraocular lens.
61
NIZLens Iris Reconstruction3[886.3600]Intraocular lens.
62
NAALens Intraocular Accommodative3[886.3600]Intraocular lens.
63
LMLLigaments And Tendons Synthetic3
64
KFJMaterials Repair Or Replacement Pacemaker3[870.3710]Pacemaker repair or replacement material.
65
PAIMesh Surgical Non-Synthetic Urogynecologic For Pelvic Organ Prolapse Transvaginally Placed3[884.5980]
66
OTPMesh Surgical Synthetic Urogynecologic For Pelvic Organ Prolapse Transvaginally Placed3[884.5980]
67
KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3[888.3480]Knee joint femorotibial metallic constrained cemented prosthesis.
68
KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3[888.3680]Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
69
DQGMicrosphere Trace3[870.1360]Trace microsphere.
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NAWMicrospheres Radionuclide3
71
NKMMitral Valve Repair Devices3
72
LIIMonitor Intracranial Pressure Implanted3
73
PIMNeuromodulator For Obesity3
74
MAEOccluder Patent Ductus Arteriosus3
75
DSZPacemaker Battery3[870.3610]Implantable pacemaker pulse generator.
76
EZTPacemaker Bladder3[876.5270]Implanted electrical urinary continence device.
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OSRPacemaker/Icd/Crt Non-Implanted Components3
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NVYPermanent Defibrillator Electrodes3
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DTBPermanent Pacemaker Electrode3[870.3680]Cardiovascular permanent or temporary pacemaker electrode.
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KXCProsthesis Ankle Cemented Non-Constrained3[888.3120]Ankle joint metal/polymer non-constrained cemented prosthesis.
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NTGProsthesis Ankle Uncemented Non-Constrained3
82
FWMProsthesis Breast Inflatable Internal Saline3[878.3530]Silicone inflatable breast prosthesis.
83
FTRProsthesis Breast Noninflatable Internal Silicone Gel-Filled3[878.3540]Silicone gel-filled breast prosthesis.
84
KWJProsthesis Elbow Hemi- Humeral Metal3[888.3180]Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
85
LBCProsthesis Finger Constrained Metal Cemented3[888.3210]Finger joint metal/metal constrained cemented prosthesis.
86
KWEProsthesis Finger Constrained Metal Uncemented3[888.3200]Finger joint metal/metal constrained uncemented prosthesis.
87
KWGProsthesis Finger Constrained Metal/Polymer3[888.3220]Finger joint metal/polymer constrained cemented prosthesis.
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KXDProsthesis Hip Constrained Metal3[888.3300]Hip joint metal constrained cemented or uncemented prosthesis.
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KWBProsthesis Hip Hemi- Acetabular Cemented Metal3[888.3370]Hip joint (hemi-hip) acetabular metal cemented prosthesis.
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KXBProsthesis Hip Pelvifemoral Resurfacing Metal/Polymer3[888.3410]Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
91
OCGProsthesis Hip Pelvifemoral Resurfacing Metal/Polymer Uncemented3[888.3410]Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
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JDLProsthesis Hip Semi-Constrained (Metal Cemented Acetabular Component)3[888.3320]Hip joint metal/metal semi-constrained with a cemented acetabular component prosthesis.
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KWAProsthesis Hip Semi-Constrained (Metal Uncemented Acetabular Component)3[888.3330]Hip joint metal/metal semi-constrained with an uncemented acetabular component prosthesis.
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OVOProsthesis Hip Semi-Constrained Ceramic-On-Metal Articulation3
95
LPFProsthesis Hip Semi-Constrained Metal/Ceramic/Ceramic Cemented3
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MRAProsthesis Hip Semi-Constrained Metal/Ceramic/Ceramic/Metal Cemented Or Uncemented3
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NXTProsthesis Hip Semi-Constrained Metal/Metal Resurfacing3
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MJOProsthesis Intervertebral Disc3
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NRAProsthesis Knee Femorotibial Unicompartmental Semi-Constrained Metal/Polymer Mobile Bearing3
100
HSAProsthesis Knee Hemi- Femoral3[888.3570]Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
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ClassIII_PMA_implants.csv