POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER
FDA premarket approval P040002/S014 · decided 2008-03-05
Approval details
- PMA number
- P040002
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2007-12-26
- Decision date
- 2008-03-05
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE REMOVAL OF THE STEEL HYPOTUBE FROM THE 21FR BIFURCATED DELIVERY SYSTEM, THE 17FR STRAIGHT DELIVERY SYSTEM, AND THE 19FR DELIVERY SYSTEM.
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