PMA P010032S108
- Device
- EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S108
- Product code
- LGW
- Decision date
- 2016-03-07
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for changes to the packaging configuration of the External Pulse Generator, 2Port Header (Model3032) used with the External Pulse Generator (Model3599) approved under P010032/S092. Specifically, you propose to remove a component, the magnet, from the EPG header kit (model 3032) to allow for separate distribution. In addition, also requested updates to the EPG Clinician’s manual and the MLTC Clinician’s manual.
Current openFDA PMA Record#
- Device
- EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S108
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-03-07
- Decision code
- APPR
- Date received
- 2015-12-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the packaging configuration of the External Pulse Generator, 2Port Header (Model3032) used with the External Pulse Generator (Model3599) approved under P010032/S092. Specifically, you propose to remove a component, the magnet, from the EPG header kit (model 3032) to allow for separate distribution. In addition, also requested updates to the EPG Clinician’s manual and the MLTC Clinician’s manual.