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 | catheter, peripheral, atherectomy |
Generic Name | catheter, peripheral, atherectomy |
Regulation Number | 870.4875 |
Applicant |
ELANA INC. |
10480 little patuxent pkwy. |
suite 400 |
columbia, MD 21044 |
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HDE Number | H080005 |
Supplement Number | S009 |
Date Received | 09/13/2012 |
Decision Date | 11/05/2012 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at spectranetics corporation, 9965 federal drive, colorado springs, co 80906 to manufacture the elana catheter 2. 0. |
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