PMA P010032S024
- Device
- ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S024
- Product code
- LGW
- Decision date
- 2008-02-07
- 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 LABELING FOR THE QUIKLINK CONTROLLER, MODEL 3860.
Current openFDA PMA Record#
- Device
- ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S024
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2008-02-07
- Decision code
- APPR
- Date received
- 2008-01-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING FOR THE QUIKLINK CONTROLLER, MODEL 3860.