Zilver PTX Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S032 · decided 2019-03-26
Approval details
- PMA number
- P100022
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zilver PTX Drug-Eluting Peripheral Stent
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2018-12-26
- Decision date
- 2019-03-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval to modify the 40-120 mm stent length delivery systems.
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