Zilver® PTX® Peripheral Drug-Eluting Stent
FDA premarket approval P100022/S041 · decided 2023-03-16
Approval details
- PMA number
- P100022
- Supplement
- S041
- 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
- 2023-02-15
- Decision date
- 2023-03-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Alternative supplier of an adhesive used in the manufacture of the delivery system.
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