PMA P100022S020
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S020
- Product code
- NIU
- Decision date
- 2016-12-28
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100022S020B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S020
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2016-12-28
- Decision code
- APPR
- Date received
- 2016-07-05
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.