GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
FDA premarket approval P010032 · decided 2001-11-21
Approval details
- PMA number
- P010032
- Trade name
- GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2001-05-29
- Decision date
- 2001-11-21
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM. THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET. THE DEVICE IS 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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