GENESIS NEUROSTIMULATION (IPG) SYSTEM
FDA premarket approval P010032/S005 · decided 2002-12-23
Approval details
- PMA number
- P010032
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESIS NEUROSTIMULATION (IPG) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-10-24
- Decision date
- 2002-12-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- 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.
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