PMA P130028S009

Device
ALGOVITA SPINAL CORD STIMULATION SYSTEM
Applicant
Nuvectra Corporation
PMA number
P130028
Supplement
S009
Product code
LGW
Decision date
2016-07-14
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for software and instructions for use (IFU) changes to the Model 4500 Clinician Programmer.

Current openFDA PMA Record#

Device
ALGOVITA SPINAL CORD STIMULATION SYSTEM
Applicant
Nuvectra Corporation
PMA number
P130028
Supplement
S009
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2016-07-14
Decision code
APPR
Date received
2016-05-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software and instructions for use (IFU) changes to the Model 4500 Clinician Programmer.