Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PROTEGE SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S074 |
Date Received | 12/23/2013 |
Decision Date | 03/21/2014 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI IPG TO PROTÉGÉ (MODEL 3789); LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI LE CHARGE TO PRODIGY CHARGER (MODEL 3730); AND MINOR SOFTWARE MODIFICATIONS TO THE PATIENT PROGRAMMER AND RAPID PROGRAMMER (MODEL 3852) TO RECOGNIZE THE DEVICE WITH THE NEW PROTÉGÉ DEVICE NAME AND MODEL NUMBER. |
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