Zilver PTX Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S022 · decided 2017-05-02
Approval details
- PMA number
- P100022
- Supplement
- S022
- Supplement type
- Real-Time Process
- 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
- 2017-03-03
- Decision date
- 2017-05-02
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for the extension of the shelf life of the Zilver PTX Drug-Eluting Peripheral Stent to 24 months.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.