Zilver® PTX® Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S038 · decided 2021-11-02
Approval details
- PMA number
- P100022
- Supplement
- S038
- 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
- 2021-08-11
- Decision date
- 2021-11-02
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use
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