ZILVER PTX Drug-Eluting Peripheral Stent.
FDA premarket approval P100022/S028 · decided 2018-08-29
Approval details
- PMA number
- P100022
- Supplement
- S028
- 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
- 2018-08-01
- Decision date
- 2018-08-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Addition of a delivery system component specification and changes to a supplier's extrusion line.
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