GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS
FDA premarket approval P010032/S039 · decided 2011-11-02
Approval details
- PMA number
- P010032
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-06-20
- Decision date
- 2011-11-02
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL TO ADD AN ELECTRONIC SWITCH SUPPLIER FOR THE DEVICE.
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