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 | GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI) |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S098 |
Date Received | 08/04/2015 |
Decision Date | 11/02/2015 |
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 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS. |
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