ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022 · decided 2012-11-14
Approval details
- PMA number
- P100022
- Trade name
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2010-06-04
- Decision date
- 2012-11-14
- Days to decision
- 894 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO OR RESTENOTIC SYMPTOMATIC LESIONS IN NATIVE VASCULAR DISEASE OF THE ABOVE-THE-KNEE FEMOROPOPLITEAL ARTERIES HAVING REFERENCE VESSEL DIAMETERS FROM 4 MM TO 9 MM AND TOTAL LESION LENGTHS UP TO 140 MM PER LIMB AND 280 MM PER PATIENT.
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