Zilver® PTX® Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S045 · decided 2026-03-25
Approval details
- PMA number
- P100022
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2026-03-02
- Decision date
- 2026-03-25
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- an approval for a change in the annual monitoring stability study sampling plan
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