RX HERCULINK ELITE RENAL STENT SYSTEM
FDA premarket approval P110001 · decided 2011-07-20
Approval details
- PMA number
- P110001
- Trade name
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Abbott Vascular
- Date received
- 2011-01-03
- Decision date
- 2011-07-20
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- 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 TRANSLESI
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510(k) clearances by this applicant
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