Zilver® PTX® Peripheral Drug-Eluting Stent
FDA premarket approval P100022/S044 · decided 2025-07-03
Approval details
- PMA number
- P100022
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zilver® PTX® Peripheral Drug-Eluting Stent
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2025-06-06
- Decision date
- 2025-07-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- a supplier change for PTFE powder used in the delivery system
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