PMA P010032S073
- Device
- EON MINI IPG NEUROSTIMULATION SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S073
- Product code
- LGW
- Decision date
- 2014-04-25
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC, IN ARECIBO, PUERTO RICO.
Current openFDA PMA Record#
- Device
- EON MINI IPG NEUROSTIMULATION SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S073
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-04-25
- Decision code
- APPR
- Date received
- 2013-07-29
- 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, IN ARECIBO, PUERTO RICO.