Zilver PTX Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S030 · decided 2018-12-20
Approval details
- PMA number
- P100022
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Zilver PTX Drug-Eluting Peripheral Stent
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2018-10-09
- Decision date
- 2018-12-20
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval to update the labeling to include post-approval study clinical data.
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