COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P090006/S002 · decided 2011-02-15
Approval details
- PMA number
- P090006
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular
- Date received
- 2010-07-19
- Decision date
- 2011-02-15
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE 120MM LENGTH COMPLETE SE VASCULAR STENT.
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