ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S014 · decided 2016-01-06
Approval details
- PMA number
- P100022
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- 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
- 2015-06-18
- Decision date
- 2016-01-06
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR CHANGES TO THE DELIVERY SYSTEM OF THE DEVICE.
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