| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
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| Generic Name | STENT, RENAL |
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| Applicant | COOK MEDICAL INCORPORATED
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402-0489 |
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| PMA Number | P100028 |
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| Date Received | 07/19/2010 |
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| Decision Date | 01/14/2011 |
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| Product Code |
NIN |
| Docket Number | 11M-0056 |
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| Notice Date | 01/26/2011 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT00631540
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE FORMULA BALLOON- EXPANDABLE 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 LESION (<= 18 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE RENAL OSTIUM AND WITH A REFERENCE VESSEL DIAMETER OF 4.0 - 7.0 MM. SUPOPTIMAL PTRA IS DEFINED AS >= 50% RESIDUAL STENOSIS, >= 20 MMHG SYSTOLIC OR >= 10 MMHG MEAN TRANSLESIONAL PRESSURE GRADIENT, OR FLOW-LIMITING DISSECTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 |
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