PMA P010032S005
- Device
- GENESIS NEUROSTIMULATION (IPG) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S005
- Product code
- LGW
- Decision date
- 2002-12-23
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR THE QUICK LINK CONTROLLER MODEL 3860 FOR USE WITH THE GENESIS MODEL 3608, 3609, 3644 AND 3604 IMPLANTED PULSE GENERATORS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
Current openFDA PMA Record#
- Device
- GENESIS NEUROSTIMULATION (IPG) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S005
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2002-12-23
- Decision code
- APPR
- Date received
- 2002-10-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE QUICK LINK CONTROLLER MODEL 3860 FOR USE WITH THE GENESIS MODEL 3608, 3609, 3644 AND 3604 IMPLANTED PULSE GENERATORS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.