ZILVER VASCULAR STENT
FDA premarket approval P050017/S002 · decided 2009-02-03
Approval details
- PMA number
- P050017
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZILVER VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2008-03-10
- Decision date
- 2009-02-03
- Days to decision
- 330 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.
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