Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Trade Name | SOLETRA/KINETRA INS |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S016 |
Date Received | 04/04/2011 |
Decision Date | 05/04/2011 |
Product Code | |
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 Implementation of newly validated process parameters for the blister sealing machine at medtronic puerto rico operations company (mproc) located in juncos, puerto rico. |
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