PMA P010032S050

Device: GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S050
Product code: LGW
Decision date: 2013-06-26
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: APPROVAL FOR THE ADDITION OF SEVERAL PIECES OF EQUIPMENT THAT ARE NEW TO THE MANUFACTURING PROCESS AS WELL AS THE RELOCATION OF EQUIPMENT AND THE ADDITION OF AN ALREADY APPROVED PIECE OF EQUIPMENT TO THE BILBY ROAD FACILITY LOCATION.

Current openFDA PMA Record#

Device: GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S050
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2013-06-26
Decision code: APPR
Date received: 2012-04-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF SEVERAL PIECES OF EQUIPMENT THAT ARE NEW TO THE MANUFACTURING PROCESS AS WELL AS THE RELOCATION OF EQUIPMENT AND THE ADDITION OF AN ALREADY APPROVED PIECE OF EQUIPMENT TO THE BILBY ROAD FACILITY LOCATION.