- Device
- GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S091
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-09-25
- Decision code
- APPR
- Date received
- 2014-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at St. Jude Medical Puerto Rico LLC, Lot. A Interior #2 Street, Km. 67.5 Santana Industrial Park, Arecibo, PR