|
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 |
|
HDE Number | H080005 |
Supplement Number | S003 |
Date Received | 11/08/2011 |
Decision Date | 12/07/2011 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following labeling charges:1) revision of the contraindications to be consistent with those in the summary of safetv and probable benefit (sspb); and2) the inclusion of a new caution regarding spastic vessels. |