POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
FDA premarket approval P040002/S029 · decided 2011-01-20
Approval details
- PMA number
- P040002
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2010-11-18
- Decision date
- 2011-01-20
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CONSOLIDATION OF ALL INNER CORE CONFIGURATIONS FOR THE 17FR INTUITRAK ACCESSORY DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POWERLINK STENT GRAFT SYSTEM WITH INTUITRAK DELIVERY SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS.
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