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 | RECLAIM DBS THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD) SYSTEM |
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 | S094 |
Date Received | 11/17/2014 |
Decision Date | 11/04/2015 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
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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