ENDOLOGIX, INC. POWERLINK SYSTEM
FDA premarket approval P040002/S019 · decided 2008-11-04
Approval details
- PMA number
- P040002
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOLOGIX, INC. POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2008-07-01
- Decision date
- 2008-11-04
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE 34MM INFRARENAL PROXIMAL CUFF ACCESSORY FOR THE POWERLINK SYSTEM.
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