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 | ELANA Surgical Kit |
Classification Name | surgical kit |
Generic Name | surgical kit |
Applicant |
ELANA INC. |
10480 little patuxent pkwy. |
suite 400 |
columbia, MD 21044 |
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HDE Number | H080005 |
Supplement Number | S010 |
Date Received | 07/13/2016 |
Decision Date | 08/15/2016 |
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 Implement parametric release for products sterilized at terumo bct, under the currently validated ethylene oxide sterilization cycle. |
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