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. |
|
Trade Name | ELANA ARTERIOTOMY SYSTEM |
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 |
|
HDE Number | H080005 |
Supplement Number | S001 |
Date Received | 06/15/2011 |
Decision Date | 09/15/2011 |
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 sterigenics, salt lake facility, 5725 harold gatty drive, salt lake city, utah as an alternative sterilization facility for the elana 2. 0catheter. |
|
|