PMA P010032S104
- Device
- GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S104
- Product code
- LGW
- Decision date
- 2015-11-06
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- TO USE AN ALTERNATIVE BATCH TEST METHOD FOR ENDOTOXIN MONITORING FOR THE GENESIS/EON/EONC/EON MINI/PROTEGE/BRIO FAMILIES OF DEVICES.
Current openFDA PMA Record#
- Device
- GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S104
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-11-06
- Decision code
- OK30
- Date received
- 2015-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO USE AN ALTERNATIVE BATCH TEST METHOD FOR ENDOTOXIN MONITORING FOR THE GENESIS/EON/EONC/EON MINI/PROTEGE/BRIO FAMILIES OF DEVICES.