FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
FDA premarket approval P100028 · decided 2011-01-14
Approval details
- PMA number
- P100028
- Trade name
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Cook Medical Incorporated
- Date received
- 2010-07-19
- Decision date
- 2011-01-14
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- 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 PRESSUR
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