PMA P130028S011
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S011
- Product code
- LGW
- Decision date
- 2016-08-12
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Addition of 1) supplemental functional inspection; and 2) regular monitoring process of non-implantable electronic devices with integral batteries.
Current openFDA PMA Record#
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S011
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-08-12
- Decision code
- OK30
- Date received
- 2016-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of 1) supplemental functional inspection; and 2) regular monitoring process of non-implantable electronic devices with integral batteries.