COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P090006/S003 · decided 2011-01-14
Approval details
- PMA number
- P090006
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular
- Date received
- 2010-11-26
- Decision date
- 2011-01-14
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED IN OFFALY, IRELAND.
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