|
Device | RX HERCULINK ELITE RENAL STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110001 |
Date Received | 01/03/2011 |
Decision Date | 07/20/2011 |
Product Code |
NIN |
Docket Number | 11M-0564 |
Notice Date | 08/01/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00490841
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE RX HERCULINK ELITE RENAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<= 15 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE RENAL OSTIUM AND WITH A REFERENCE VESSEL DIAMETER OF 4.0 - 7.0 MM. SUBOPTIMAL PTRA IS DEFINED AS >= 50% RESIDUAL STENOSIS, >= 20 MMHG PEAK SYSTOLIC OR >= 10 MMHG MEAN TRANSLESIONAL PRESSURE GRADIENT, FLOW-LIMITING DISSECTION, OR TIMI [THROMBOLYSIS IN MYOCARDIAL INFARCTION] FLOW <= 3. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S020 |