Tier

2

TABLE 3.-MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD1-Continued

Device Name

2222

22

222

22

Root canal filling resin (other
than chloroform use)
Porcelain tooth

Extraoral source x-ray system
Intraoral source x-ray system
Intraosseous fixation screw or
wire

Endodontic stabilizing splint
Orthodontic plastic bracket

Audiometer

Auditory impedance tester
Electronic noise generator for
audiometric testing
Electroglottograph

Surgical nerve stimulator/loca

tor

Hearing aid (for bone-conduc-
tion)

Hearing aid calibrator and
analysis system

Group hearing aid or group
auditory trainer
Master hearing aid
Ear, nose, and throat electric
or pneumatic surgical drill
Argon laser for otology, rhi-
nology, and laryngology
Ear, nose, and throat micro-
surgical carbon dioxide
laser

2

2 2

2

1

2

2

TABLE 3.-MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD1-Continued

Rigidity analyzer
Alpha monitor
Cutaneous electrode
Nasopharyngeal electrode
Needle electrode

Electroencephalograph
Nystagmograph

Neurological endoscope

Galvanic skin response meas-
urement device

Nerve conduction velocity

measurement device
Skin potential measurement
device

Powered direct-contact tem-
perature measurement de-
vice

Intracranial pressure moni-
toring device

Physiological signal amplifier
Physiological signal condi-
tioner

Electroencephalogram (EEG)
telemetry system
Biofeedback device

Echoencephalograph

Radiofrequency lesion gener-
ator

Electrode, spinal epidural
Powered compound cranial
drills, burrs, trephines, and
their accessories
Powered simple cranial drills
burrs, trephines, and their
accessories

Electric cranial drill motor

Pneumatic cranial drill motor
Stereotaxic instrument
Radiofrequency lesion probe
Powered rongeur
Lesion temperature monitor
Evoked response electrical
stimulator

Evoked response mechanical
stimulator

Evoked response photic stim-
ulator

Evoked response auditory

stimulator

Tremor transducer

Transcutaneous electrical

nerve stimulator for pain re-
lief

22

2

1

22

222222222

2

2 2

2 22

2

222

22

2

2222222

2

2 2 2 2

TABLE 3.-MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD1-Continued

2

Hysteroscope and acces-
sories (for performance
standards)
Obstetric-gynecologic ultra-
sonic imager
Fetal cardiac monitor
Fetal phonocardiographic
monitor and accessories
Fetal ultrasonic monitor and
accessories

Fetal scalp circular (spiral)
electrode and applicator
Intrauterine pressure monitor
and accessories
External uterine contraction

monitor and accessories
Perinatal monitoring system
and accessories

Obstetric ultrasonic transducer
and accessories
Gynecologic laparoscope and
accessories

Unipolar endoscopic coagu

lator-cutter and accessories
Gynecologic surgical laser
Gynecologic electrocautery
and accessories
Condom

Eye sphere implant
Polymethylmethacrylate

(PMMA) diagnostic contact
lens

Rigid gas permeable contact

lens (daily wear only)

Opthalmic camera

Corneal electrode

Euthyscope (AC-powered)

Visual field laser instrument
Eye movement monitor

2

22

2

1

2

2

2

2

2

2

22

222

886.5916

2

1

886.1220

1

886.1250

1

TABLE 3.-MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD1-Continued

22

112222

222

2

2

2

22

Spinal intervertebral body fixa-
tion orthosis

AC-powered dynamometer
Sonic surgical instrument and
accessories/attachments

Accessories, fixation, spinal
interlaminal

Accessories, fixation, spinal
intervertebral body

Monitor, pressure,

intracompartmental
Orthosis, fixation, spinal
intervertebral fusion
Orthosis, spinal pedicle fixa-
tion

System, cement removal ex-
traction

Chronaximeter

2

2

1 2

1

2

TABLE 3.-MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING OPERATIONAL PERIOD1-Continued

'Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at "http://www.fda.gov/cdrh/prodcode.html”.