PMA P010032S110
- Device
- EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S110
- Product code
- LGW
- Decision date
- 2016-03-22
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for a material change to the approved pouch used with the External Pulse Generator, 16 Channel (Model 3599).
Current openFDA PMA Record#
- Device
- EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S110
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-03-22
- Decision code
- APPR
- Date received
- 2015-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the approved pouch used with the External Pulse Generator, 16 Channel (Model 3599).