PMA P010032S063
- Device
- EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S063
- Product code
- LGW
- Decision date
- 2013-04-11
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR REPLACING THE CURRENT CONTRAINDICATION REGARDING USE OF THENEUROSTIMULATOR IN PATIENTS WITH DEMAND-TYPE CARDIAC PACEMAKERS WITH A WARNING STATEMENT THAT RECOMMENDS INTERACTION TESTING AND AVOIDING UNIPOLAR PROGRAMMING OF THE NEUROSTIMULATOR.
Current openFDA PMA Record#
- Device
- EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S063
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-04-11
- Decision code
- APPR
- Date received
- 2012-10-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REPLACING THE CURRENT CONTRAINDICATION REGARDING USE OF THENEUROSTIMULATOR IN PATIENTS WITH DEMAND-TYPE CARDIAC PACEMAKERS WITH A WARNING STATEMENT THAT RECOMMENDS INTERACTION TESTING AND AVOIDING UNIPOLAR PROGRAMMING OF THE NEUROSTIMULATOR.