Stimulator, Neuromuscular, Implanted

Device Code: 5054

Product Code(s): GZC

Definition: Call For PMAs To Be Filed By 7/13/99 Per 64 FR 18329 On 4/14/99

Device Classification Information

Device Type ID5054
Device NameStimulator, Neuromuscular, Implanted
Regulation DescriptionImplanted Neuromuscular Stimulator.
Regulation Medical SpecialtyNeurology
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission TypePMA
CFR Regulation Number882.5860 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeGZC
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5054
DeviceStimulator, Neuromuscular, Implanted
Product CodeGZC
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionImplanted Neuromuscular Stimulator.
CFR Regulation Number882.5860 [🔎]
TPLC Last Update: 2019-04-02 20:59:26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.