ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S011 · decided 2015-01-13
Approval details
- PMA number
- P100022
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2014-11-12
- Decision date
- 2015-01-13
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL TO THE POST-APPROVAL STUDY FOR THE DEVICE TO ALLOW FOR ENROLLMENT OF JAPANESE PMS PATIENTS WITH LESION LENGTH UP TO 200 MM PER LIMB IS COMPLETE.
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