Definition: Call For PMAs To Be Filed By 7/13/99 Per 64 FR 18329 On 4/14/99
Device Type ID | 5054 |
Device Name | Stimulator, Neuromuscular, Implanted |
Regulation Description | Implanted Neuromuscular Stimulator. |
Regulation Medical Specialty | Neurology |
Review Panel | Physical Medicine |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | PMA |
CFR Regulation Number | 882.5860 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | GZC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 5054 |
Device | Stimulator, Neuromuscular, Implanted |
Product Code | GZC |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Implanted Neuromuscular Stimulator. |
CFR Regulation Number | 882.5860 [🔎] |