Zilver® PTX® Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S040 · decided 2022-02-02
Approval details
- PMA number
- P100022
- Supplement
- S040
- Supplement type
- Real-Time Process
- 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
- 2021-11-04
- Decision date
- 2022-02-02
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for an additional active pharmaceutical ingredient supplier.
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