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 | MEDTRONIC MODEL 7482 DBS EXTENSION |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S026 |
Date Received | 07/15/2002 |
Decision Date | 10/31/2002 |
Product Code |
MHY |
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 THE FOLLOWING CHANGES TO THE APPROVED MODEL 7482 DBS EXTENSION; COMBINE LOW PROFILE DESIGN AND TECHNOLOGY WITH A LOW IMPEDANCE CONDUCTOR, CHANGE THE COATING USED ON THE OUTSIDE DIAMETER TO SILOXANE, ADD A NEW TORQUE WRENCH TO THE EXTENSION PACKAGE, AND ADD A NEW MODEL 3550-25 BOOTS ACCESSORY KIT. |
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