|
Device | GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S104 |
Date Received | 10/07/2015 |
Decision Date | 11/06/2015 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |