Zilver® PTX® Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S039 · decided 2022-05-13
Approval details
- PMA number
- P100022
- Supplement
- S039
- Supplement type
- 135 Review Track For 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
- 2021-09-30
- Decision date
- 2022-05-13
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for a site change of an Active Pharmaceutical Ingredient (API) supplier.
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