GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
FDA premarket approval P010032/S152 · decided 2019-07-17
Approval details
- PMA number
- P010032
- Supplement
- S152
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-06-17
- Decision date
- 2019-07-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Implement a manufacturing process change that changes the in-process electrode cleaning method for the S-Series Leads from one ultrasonic cleaning method to another.
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