Zilver PTX Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S034 · decided 2019-09-13
Approval details
- PMA number
- P100022
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Zilver PTX Drug-Eluting Peripheral Stent
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2019-09-03
- Decision date
- 2019-09-13
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for updates to the device labeling.
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