ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S020 · decided 2016-12-28
Approval details
- PMA number
- P100022
- Supplement
- S020
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2016-07-05
- Decision date
- 2016-12-28
- Days to decision
- 176 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 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 diameter from 4 mm to 7 mm and total lesion lengths up to 300 mm per patient.
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